Infusion pump system with disposable cartridge having pressure venting and pressure feedback

ABSTRACT

Embodiments are directed to portable infusion devices, systems, and methods of using the same for dispensing materials. In some cases, the devices, systems and methods may be used for infusing a material such as medicament, e.g., insulin, into a body in need thereof.

RELATED APPLICATIONS

This application claims priority from U.S. Provisional PatentApplication Ser. No. 61/230,061, titled Infusion System and Methods forUsing Same, filed Jul. 30, 2009, by P. DiPerna et al., which is alsoincorporated by reference herein in its entirety. This application isalso related to U.S. patent application Ser. No. ______, attorney docketnumber TDM-1500-UT, titled Infusion Pump System with DisposableCartridge Having Pressure Venting and Pressure Feedback, filed Jul. 29,2010, by B. Bureson, et al., U.S. patent application Ser. No. ______,attorney docket number TDM-1500-UT2, titled Infusion Pump System withDisposable Cartridge Having Pressure Venting and Pressure Feedback,filed Jul. 29, 2010, by G. Kruse, et al., U.S. patent application Ser.No. ______, attorney docket number TDM-1500-UT4, titled Infusion PumpSystem with Disposable Cartridge Having Pressure Venting and PressureFeedback, filed Jul. 29, 2010, by M. Michaud, et al., U.S. patentapplication Ser. No. ______, attorney docket number TDM-1500-UT5, titledInfusion Pump System with Disposable Cartridge Having Pressure Ventingand Pressure Feedback, filed Jul. 29, 2010, by P. DiPerna, et al., andPCT Patent Application No. ______, attorney docket number TDM-1500-PC,titled Infusion Pump System with Disposable Cartridge Having PressureVenting and Pressure Feedback, filed Jul. 29, 2010, by P. DiPerna, etal., all of which are incorporated by reference herein in theirentirety.

FIELD OF THE INVENTION

This disclosure is directed to portable infusion devices, systems, andmethods of using the same for dispensing materials. In some cases, thedevices, systems and methods may be used for infusing a material such asmedicament, e.g., insulin, into a body in need thereof.

BACKGROUND

There are many applications in academic, industrial, and medical fields,as well as others, that may benefit from devices and methods that arecapable of accurately and controllably delivering fluids, includingliquids and gases that have a beneficial effect when administered inknown and controlled quantities. This may be particularly true in themedical field where much of the treatment for a large percentage ofpatients includes the administration of a known amount of a substance atpredetermined intervals. The treatment of diabetes often involves justsuch a regimented dosage of materials, in particular, the administrationof insulin. In addition, the administration of insulin for a diabeticpatient is one of a few medical indications wherein the patientroutinely administers the medicament to themselves by a subcutaneousmodality, such as a hypodermic syringe injection. As such, providing apatient with the means to safely, reliably and comfortably administerrequired doses of medication may be particularly important in order tofacilitate patient compliance and accurate treatment of the condition.

Blood glucose is an important factor for metabolism and the provision ofenergy and proper organ functioning in mammals. The accurate regulationof blood glucose is, therefore, an essential task necessary for the wellbeing of the mammal. For instance, the neurons of the brain of anorganism depend on glucose for fueling their functioning. Hence, bloodglucose levels are typically regulated by feedback loops between thebrain and the pancreas. The pancreas functions in response to varioushormones released by the brain by itself releasing hormones thatregulate the uptake, e.g., storage, of blood sugar, or the release ofstored blood sugar. For instance, two essential hormones in theregulation of blood sugar levels are insulin and glucagon, both of whichare synthesized by specialized cells in the pancreas. Specifically, theβ cells of the islets of Langerhans function to synthesize insulin,while the a cells of the islets of Langerhans function to synthesizeglucagon.

Maintaining appropriate blood glucose homeostasis is an important factorfor promoting the length and quality of life. However, there are manyfactors that affect the body's ability to maintain such homeostasis. Forinstance, factors such as the body's ability to produce or respond toinsulin, one's physiological condition and/or health, the quantity andtype of food one eats, one's metabolic rate, activity level, the typesof activities and the exertion level in which one engages, as well asother such factors that make up a person's daily life and/or routine,all play important roles in effecting the body's ability to maintainhomeostasis.

Continuous subcutaneous insulin injection and/or infusion therapy isinitiated for the replacement of insulin and thereby the treatment ofdiabetes. Such therapy may include the regular and/or continuousinjection or infusion of insulin into the skin of a person sufferingfrom diabetes. Injection is the traditional and most common method foradministering insulin. Typically the diabetic will measure his or herblood glucose level, and depending on the level thereof may prepare asyringe or injection pen with insulin to be injected transdermally intothe body. However, recently, insulin injecting pumps have been developedfor the administration of insulin for those suffering from both type Iand II diabetes. Insulin pumps are medical devices used for theadministration of insulin in the treatment of diabetes and offer analternative to multiple daily injections of insulin by an insulinsyringe or an insulin pen. They also allow for continuous insulintherapy.

There are, however, several drawbacks associated with the use ofsubcutaneous injection syringes and/or some currently available infusionpumps for the delivery of insulin. Patient compliance, for instance, isa major problem with respect to the use of insulin syringes. A highpercent of subjects suffering from diabetes experience dread when itcomes to insulin injections due to the anxiety and discomfort associatedwith regular use of a the needle therefore. Further complicationsinvolve the cost of the syringes, which cost may lead to the spread ofinfections and diseases, such as human immunodeficiency virus (H IV) andhepatitis, through the sharing and/or reusing of needles. In addition,diabetes patients who choose to use commercially available pumps toavoid the disadvantages of syringe delivery often find that wearing themtogether with their required infusion set tubing is uncomfortable orunwieldy, particularly while participating in sporting activities orwhile sleeping.

Some commercially available pumps are designed to be smaller thanothers, but typically include a patch type element that may be adhereddirectly to the skin. Such a pump may contain the insulin reservoir,pumping mechanism, power supply as well as an infusion set and automatedinsert. The patch may be quite a bit heavier than typical infusion setpatches. This may pose the problem of the infusion set slowly beingpulled out of the patient due to the weight of the patch itselfresulting in waste and inaccuracies in treatment. Once the patch isinadvertently knocked off the skin or loosened there may be no means toreinsert the infusion set also resulting in waste and added expense.

Furthermore, the smaller the size of an infusion pump, the moredifficult it is for a patient to interface with the device. Commerciallyavailable pumps typically have a single screen and one or more hardbuttons for enabling a user to navigate through multiple menus andscreens. A drawback of requiring a user to navigate through multiplemenus and pages to set up a delivery of insulin may be that the userfinds the process too complex and time consuming to properly use theinfusion device to its fullest potential. As a result, some users tendto “set-it and forget-it”.

Generally a patient's insulin requirements vary greatly, as mentionedabove, and may be influenced by a variety of factors (e.g., caloricintake, physiological conditions). Therefore, there is a need for a userfriendly portable infusion device that has the ability to tailorappropriate insulin delivery profiles to a user. There is also a needfor an infusion device providing an interface that facilitates its use.

SUMMARY

Some embodiments are directed to an infusion pump kit configured fordelivering a therapeutic fluid to a patient. The device may include afirst pump device including a first housing and a first drive mechanism,a second pump device comprising a second housing and a second drivemechanism, and an infusion cartridge. The infusion cartridge may furtherinclude a fluid reservoir configured to be filled with a volume of thetherapeutic fluid sufficient for a prolonged single infusion protocol.The infusion cartridge may additionally include a delivery mechanismhaving a distal end in fluid communication with an interior volume ofthe fluid reservoir and a proximal end configured to couple to eitherthe first drive mechanism or the second drive mechanism and betranslated between a plurality of linear positions to deliver thetherapeutic fluid to the patient. In addition, the infusion cartridgemay be configured to be interchangeably coupled to, and alternatedbetween, the first pump device and the second pump device during thesingle infusion protocol of the therapeutic fluid to the patient.

Some embodiments are directed to a method of delivering a therapeuticfluid to a patient. The method may include providing a first pump devicehaving a full featured user interface, installing a disposable infusioncartridge on the first pump device, and removing the disposable infusioncartridge from the first pump device. In addition, the method mayinclude installing the disposable infusion cartridge onto a second pumpdevice while maintaining the sterility of the fluid disposed within areservoir of the disposable infusion cartridge.

Some embodiments of the device may additionally include a fluid deliverysystem for delivering a therapeutic fluid to a patient. The system mayinclude a pump housing comprising a drive mechanism translatable betweena plurality of linear positions to deliver the therapeutic fluid to thepatient and an infusion cartridge removably coupled to the pump housing.The infusion cartridge may include a fillable fluid reservoir and adelivery mechanism comprising a distal end in fluid communication withan interior volume of the fluid reservoir and a drive coupling disposedat a proximal end. The drive coupling may be further configured toreceive and couple to a drive portion of the drive mechanism independentof the linear position of the drive mechanism.

Some embodiments of the device are directed at a method of coupling adisposable fluid reservoir cartridge to an infusion pump device. Themethod may include providing an infusion pump device including a driveportion of a drive mechanism that includes a ball or capturable featureat an end of a drive shaft. The method may further include providing adisposable fluid reservoir cartridge including a drive coupling of adelivery mechanism that comprises a flexible female receptacleconfigured to snap fit over the ball of the drive shaft with the ballintroduce from either a lateral direction or axial direction. The methodmay additionally include returning the ball of the drive mechanism to ahome position at a proximal position of a drive stroke, inserting thedisposable fluid reservoir cartridge onto the infusion pump device, andadvancing the ball of the drive shaft of the drive mechanism from theproximal position to engage and snap fit with the flexible femalereceptacle of the delivery mechanism of the cartridge.

Some embodiments are directed to a method of switching a fluid reservoircartridge from a first pump device to a second pump device. The methodmay include providing a first infusion pump device including a driveportion of a drive mechanism that includes a ball or capturable featureat an end of a drive shaft. The method may further include providing adisposable fluid reservoir cartridge including a drive coupling of adelivery mechanism that comprises a flexible female receptacle which issnap fit over the ball of the drive shaft and which is configured torelease the ball from either a lateral direction or axial direction. Themethod may additionally include returning the ball of the drivemechanism to a home position at a proximal position of a drive stroke,inserting the disposable fluid reservoir cartridge onto the infusionpump device, and advancing the drive shaft of the drive mechanism fromthe proximal position to engage and snap fit with the flexible femalereceptacle of the delivery mechanism of the cartridge.

Some embodiments of the infusion pump system may include a housing and adisposable cartridge. The disposable cartridge may further include acollapsible reservoir surrounded by a flexible material and asubstantially rigid container sealed around the flexible material of thecollapsible reservoir. Furthermore, the cartridge may be releasablysecured to the housing. The infusion pump may further include adisposable delivery mechanism disposed within the disposable cartridgeand having a reservoir inlet port in fluid communication with aninterior volume of the reservoir. The infusion pump may additionallyinclude a drive mechanism including a motor disposed in the housing anddetachably coupled to a spool member of the delivery mechanism with thedrive mechanism being operatively coupled to the spool member. Theinfusion pump may further include at least one pressure sensor disposedin a volume disposed between the outside surface of the flexiblematerial of the reservoir and an inside surface of the substantiallyrigid container/case, a graphic user interface operatively coupled to acontroller, and a power storage cell. Additionally, the infusion pumpmay include a vent inlet port disposed on the delivery mechanism influid communication with the volume disposed between the outside surfaceof the flexible material of the reservoir and an inside surface of thesubstantially rigid container/case and a controller including at leastone processor and a memory device. The controller may be operativelycoupled to the drive mechanism, GUI, and at least one pressure sensorand configured to generate a signal to the drive mechanism to displacethe spool of the delivery mechanism.

Some embodiments of the infusion pump system may include a pump deviceincluding a housing, a drive mechanism with a motor, a controlleroperatively coupled to the drive mechanism and a slot configured toaccept a disposable fluid cartridge. The infusion pump system mayfurther include a disposable fluid cartridge which may be operativelycoupled to the housing. The disposable fluid cartridge may furtherinclude a delivery mechanism, a collapsible reservoir having an interiorvolume surrounded by a flexible fluid tight membrane, and the interiorvolume being in fluid communication with a reservoir inlet port. Thecartridge may also include a substantially rigid shell disposed over thereservoir and forming a second interior volume between an outsidesurface of the reservoir and an inside surface of the rigid shell with avent inlet port in communication with the second interior volume.Additionally, the infusion pump system may include a pressure sensordisposed between an interior surface of the rigid case and an exteriorsurface of the collapsible reservoir shell, a bore within a pump body ofthe delivery mechanism, and a spool. In addition, the spool may beslidingly disposed in the bore having a collapsible first volume whichis configured to communicate with the reservoir inlet port andoutlet/dispense port of the bore independently of each other, and asecond volume isolated from the first collapsible volume, the secondvolume configured to be moveable between a position that allows a ventinlet port to communicate with a vent outlet port and a position wherethe vent inlet and outlet ports are isolated from each other.

Some embodiments are directed to an infusion pump for dispensing fluidto a patient. The device may include a disposable fluid cartridge. Thecartridge may include a delivery mechanism, which may include a deliverymechanism body. Additionally, a bore may be disposed in the deliverymechanism body, which may further include a distal end, a proximal enddisposed towards a drive mechanism of the infusion pump, an interiorvolume, a reservoir inlet port, a fluid dispense port, a vent inletport, and a vent outlet port. The infusion pump may further include aspool slidingly disposed within the bore. The spool may further includea collapsible first volume which is positionable to overlap thereservoir inlet port independent of an overlap of the fluid dispenseport and which is formed between a first seal around the spool, a secondseal around the spool, an outer surface of the spool body between thefirst and second seal and an interior surface of the bore between thefirst and second seal. Furthermore, the first and second seals may beaxially moveable relative to each other. The spool may additionallyinclude a vent second volume, which is positionable to overlap the ventinlet port and vent outlet port simultaneously and which is formed by athird seal around the spool, a fourth seal around the spool, an outsidesurface of the spool between the third and fourth seal, and an insidesurface of the bore between the third and fourth seal. The infusion pumpmay further include a collapsible fluid reservoir bounded by a flexiblemembrane and including an interior volume in fluid communication withthe reservoir inlet port. The infusion pump may further include asubstantially rigid shell disposed about the collapsible fluid reservoirwith an interior volume that contains the collapsible fluid reservoirand a vented volume disposed between an outer surface of the flexiblemembrane and an interior surface of the rigid shell, the vent inlet portbeing in fluid communication with the vented volume. Additionally, theinfusion pump may include a drive mechanism operatively coupled to thespool of the delivery mechanism, a user interface configured toaccommodate user data input regarding fluid delivery, a controllerhaving a processor and memory device operatively coupled to the drivemechanism, and a power cell. The power cell may further be operativelycoupled to the controller, the GUI, and the drive mechanism.

Some embodiments of the device are directed at a method of venting acartridge of an infusion pump system. The method may include providingan infusion pump system, which may further include a disposable fluidreservoir cartridge. The cartridge may include a delivery mechanism,which may further include a delivery mechanism body. The device mayfurther include a bore disposed in the delivery mechanism body includinga distal end, a proximal end disposed towards a drive mechanism of theinfusion pump, an interior volume, a reservoir inlet port, a fluiddispense port, a vent inlet port and a vent outlet port. The device mayfurther include a spool slidingly disposed within the bore, which mayfurther include a collapsible first volume. The collapsible first volumemay be positionable to overlap the reservoir inlet port independent ofan overlap of the fluid dispense port and which is formed between afirst seal around the spool, a second seal around the spool, an outersurface of the spool body between the first and second seal and aninterior surface of the bore between the first and second seal, thefirst and second seals being axially moveable relative to each other.The spool may also include a vent second volume which is positionable tooverlap the vent inlet port and vent outlet port simultaneously andwhich is formed by a third seal around the spool, a fourth seal aroundthe spool, an outside surface of the spool between the third and fourthseal and an inside surface of the bore between the third and fourthseal. The device may further include a collapsible fluid reservoirbounded by a flexible membrane and including an interior volume in fluidcommunication with the reservoir inlet port. The device may additionallyinclude a substantially rigid shell disposed about the collapsible fluidreservoir with an interior volume that contains the collapsible fluidreservoir and a vented volume disposed between an outer surface of theflexible membrane and an interior surface of the rigid shell, with thevent inlet port being in fluid communication with the vented volume. Thedevice may further include a drive mechanism operatively coupled to thespool of the delivery mechanism. The method of venting a cartridge of aninfusion pump system may further include initiating a dispense cycle bydriving the spool with the drive mechanism to a position with thecollapsible first volume in communication with the reservoir inlet port.The method may further include driving the spool so as to separate thefirst and second seals of the collapsible first volume and draw fluidinto the first volume through the reservoir inlet port from thereservoir and decrease the pressure within the vented volume. The methodmay additionally include driving the spool with the drive mechanism to aposition with the collapsible first volume in communication with thefluid dispense port, driving the spool so as to at least partiallycollapse the collapsible first volume and dispense fluid from thecollapsible first volume through the fluid dispense port, and drivingthe spool to a position with the vent second volume in simultaneouscommunication with the inlet vent port and vent outlet port to allow thevent second volume to arrive at the same pressure as the vent outletport.

Some embodiments are directed to a delivery mechanism for an infusionpump. The delivery mechanism of an infusion pump may include a boredisposed in a delivery mechanism body, a spool disposed in the borewhich is axially displaceable within the bore, and a collapsible volume.The collapsible volume may be bounded by an outside surface of thespool, an inside surface of the bore, a first seal between the spool andthe bore that is axially fixed relative to the spool but displaceablerelative to an inside surface of the bore and a second seal between thespool and inside surface of the bore which is configured to slide over aslide portion of the spool disposed in an aperture of the second seal,which forms a substantially fluid tight but displaceable seal between anoutside surface of the second seal and the inside surface of the boreand which forms a fluid tight but displaceable seal between an outsidesurface of the slide portion and the second seal.

Some embodiments may be directed to an infusion pump for dispensingfluid to a patient. The device may further include a disposable fluidcartridge, which may include a delivery mechanism. The deliverymechanism may further include a delivery mechanism body. The device mayadditionally include a bore disposed in the delivery mechanism bodyincluding a distal end, a proximal end disposed towards a drivemechanism of the infusion pump, an interior volume, a reservoir inletport, a fluid dispense port, a vent inlet port and a vent outlet port.The device may further include a spool slidingly disposed within thebore, which may further include a collapsible first volume. Thecollapsible first volume may be bounded by an outside surface of thespool, an inside surface of the bore, a first seal between the spool andthe bore that is axially fixed relative to the spool but displaceablerelative to an inside surface of the bore and a second seal between thespool and inside surface of the bore which is configured to slide over aslide portion of the spool disposed in an aperture of the second seal,which forms a substantially fluid tight but displaceable seal between anoutside surface of the second seal and the inside surface of the boreand which forms a fluid tight but displaceable seal between an outsidesurface of the slide portion and the second seal. The spool may furtherinclude a vent second volume which may be positionable to overlap thevent inlet port and vent outlet port simultaneously and which may beformed by a third seal around the spool, a fourth seal around the spool,an outside surface of the spool between the third and fourth seal and aninside surface of the bore between the third and fourth seal. The devicemay further include a collapsible fluid reservoir bounded by a flexiblemembrane and including an interior volume in fluid communication withthe reservoir inlet port, a substantially rigid shell disposed about thecollapsible fluid reservoir with an interior volume that contains thecollapsible fluid reservoir, and a vented volume disposed between anouter surface of the flexible membrane and an interior surface of therigid shell, the vent inlet port being in fluid communication with thevented volume.

Some embodiments of the device may include an o-ring seal, which mayhave a gland for seating an o-ring. The seating may further include anouter circumferential groove extending circumferentially around alongitudinal axis of a cylindrical body, with the circumferential grooveincluding an angled first edge and an angled second edge opposite theangled first edge and an inner overflow channel disposed below theangled first and second edges. The o-ring seal may further include ano-ring disposed in the gland with a first circumferential band of theo-ring resting on the first angled edge and a second circumferentialband of the o-ring resting on the second angled edge above the overflowchannel with the o-ring in a substantially uncompressed state.

Some embodiments of the device may include a delivery mechanism of aninfusion pump for dispensing fluid to a patient. The delivery mechanismmay include a spool slidingly disposed in a bore of a delivery mechanismhousing, and an o-ring seal disposed on the spool. The o-ring seal mayfurther include a gland for seating an o-ring, which may include anouter circumferential groove extending circumferentially around alongitudinal axis of a cylindrical body of the spool. Thecircumferential groove may further include an angled first edge and anangled second edge opposite the angled first edge and an inner overflowchannel disposed below the angled first and second edges. The deliverymechanism may further include an o-ring disposed in the gland with afirst circumferential band of the o-ring resting on the first anglededge and a second circumferential band of the o-ring resting on thesecond angled edge above the overflow channel with the o-ring in asubstantially uncompressed state.

Some embodiments of the portable infusion device may be configured forgenerating an estimate of an amount of a fluid to be delivered to a bodyof a user. The device may further include a processor that may becoupled to a memory and configured for receiving user input data fromthe memory and using the input data for generating an estimate of anamount of fluid to be delivered to the body. The memory may beconfigured for receiving and storing user input data coupled to theprocessor and may be further configured for communicating that data tothe processor. The device may further include a touch sensitive screenconfigured for displaying at least one request for user input, wheresaid display is further configured for receiving user input in responseto the request and communicating the input to the memory.

Some embodiments of the portable infusion device may be configured forgenerating an estimate of an amount of a fluid to be delivered to a bodyof a user. The device may further include a reservoir for storing thefluid, a delivery mechanism for effecting the delivery of the fluid, anda processor coupled to a memory and configured for receiving user inputdata from the memory and using the input data for generating an estimateof an amount of fluid to be delivered to the body. The device mayfurther include a memory for receiving and storing user input datacoupled to the processor and configured for communicating that data tothe processor. The device may additionally include a display configuredfor displaying a request for a user to input data, wherein the displayis further configured for receiving user input data in response to therequest and communicating that data to the memory.

Some embodiments of the portable infusion device may be directed at amethod for delivering an amount of a fluid to a body of a user. Themethod may include providing a portable infusion device, which mayfurther include a reservoir for storing the fluid, a delivery mechanismfor delivering the fluid, and a processor for generating an estimate ofan amount of fluid to be delivered to the body in response to user inputdata and for controlling the delivery mechanism. The device may furtherinclude a data input interface for communicating with the processor thedata input interface is configured for receiving user input data. Thedevice may additionally include a display for displaying the estimate ofan amount of a fluid to be delivered and inputting externally suppliedvalues into the data input interface. The input may include data thatthe input interface receives and the user input data may be communicatedto the processor. The processor may further receive the user input data,generate an estimate of an amount of a fluid to be delivered to the bodyof the user, and communicate the estimate to the display. The device maybe further configured for receiving the generated estimate of an amountof fluid to be delivered on the display of the portable infusion deviceand receiving a request for a user input on the display of the portableinfusion device. Furthermore, the request may require the user to make aselection before delivering the amount of fluid to the body of the useror making a selection based on the estimate such that once the selectionis made the portable infusion device delivers the quantity of fluid tothe body in response to the selection.

Some embodiments of the portable infusion device may be configured forgenerating an estimate of an amount of fluid to be delivered to a bodyand delivering the amount of fluid to the body of a user in accordancewith the generated estimate. The system may further include a remotecommander that includes a processor, for generating an estimate of anamount of fluid to be delivered to a body in response to user inputdata. The system may further include a data input interface forcommunicating with the processor such that the data input interface isconfigured for receiving user input data. The system may further includea memory coupled to the processor for receiving and storing user inputdata. The system may further include a display for displaying theestimate of an amount of a fluid to be delivered and a transmitter fortransmitting a command to an infuser device such that the commandinstructs the infuser device to deliver an amount of fluid in accordancewith the generated and confirmed estimate. The system may furtherinclude a portable infusion device configured for delivering an amountof a fluid to be delivered to a body of a user in accordance with agenerated estimate. The portable infusion device may include a reservoirfor storing the fluid, a delivery mechanism for effectuating thedelivery of the fluid, a receiver for receiving the command from thetransmitter of the remote commander; and a processor for instructing thereservoir and delivery mechanism to deliver the amount of fluid to thebody of a user in accordance with the generated estimate.

Some embodiments may be directed at a kit. The kit may include aninfusion device and instructions for using the system. Some embodimentsof the portable infusion device may be configured for facilitatinginstructing a user on how to operate a portable infusion device, whichmay include a portable infusion device, a processor functionally linkedto the portable infusion device, and a user-interactive touch screendisplay functionally linked to the processor. The portable infusiondevice may further include processor instructions that are accessible bythe processor and configured to instruct the processor to load aprogram. Furthermore, the program file may include data corresponding toan arrangement of at least one of a text and graphic, that whendisplayed on the user-interactive touch screen display, providesinformation to the user. In addition, at least one of the text andgraphic may be displayed on the user-interactive touch screen that isanimated.

Some embodiments may be directed to a method of using a portableinfusion device to provide information to a user. The method of usingthe device may include providing a user with a portable infusion devicethat has a user-interactive touch screen display that displays agraphical user interface. Furthermore, the user-interactive touch screenmay display at least one object relating to at least one of a text and agraphic that may provide information to a user. In addition, at leastone object displayed on said user-interactive touch screen display maybe animated.

Some embodiments may be directed to a system for facilitating user errorprevention of a portable infusion device. The user error preventionfeature may include a portable infusion device having a processorfunctionally linked to the portable infusion device. In addition, theportable infusion device may include a user-interactive touch screendisplay functionally linked to the processor and processor instructionsthat are accessible by the processor and are configured to instruct theprocessor to display a plurality of objects on the user-interactivetouch screen display. Furthermore, at least two objects representingdifferent user input may be displayed to allow a user to select at leastone displayed object as user input and prevent a user from selecting atleast one displayed object as user input.

Some embodiments are directed to a method of using a portable infusiondevice for facilitating user error prevention. The method may includedisplaying a graphical user interface on a user-interactive touch screendisplay, which displays a plurality of objects with at least two objectsrepresenting a different user input. The method may further includeallowing a user to select at least one object as a user input andpreventing a user from selecting at least one object as user input.

Some embodiments are directed to a portable infusion device including aprocessor functionally linked to the portable infusion device and auser-interactive touch screen display functionally linked to theprocessor. The touch screen display may further include a display areathat also operates as a touch input area, which may simultaneouslydisplay a plurality of touch sensitive modifiable objects representingvarious information. Furthermore, the user-interactive touch screendisplay and processor may allow a user to touch any one of the touchsensitive modifiable objects for at least one of viewing, inputting, andmodifying information associated with the object touched by the user.

Some embodiments are directed to a device configured for generating anestimate of an amount of a fluid to be delivered to a body of a user.The device may include a processor coupled to a memory, wherein theprocessor is configured for receiving user input data from the memoryand using the input data for generating an estimate of an amount offluid to be delivered to the body. The user input data may include oneor more of a blood glucose level, a stress level, a physiologicalcondition, a complexity of a meal to be ingested, an activity level,user history, and the like. The processor may also be configured forreceiving non-user entered data and using the non-user entered data ingenerating the estimate of the amount of fluid to be delivered. Thenon-user entered data may include sensor data, data received from awireless communication device, and the like.

Some embodiments of the portable infusion device may include a processorthat executes instructions for generating an estimate of an amount offluid for delivery to a body of a user. The infusion device may alsoinclude a touch sensitive display configured for displaying at least onedisplay object, so that user interaction with the display objectgenerates a user input value. In addition, the infusion device mayinclude a data interface configured for receiving the user input valuefrom the display in response to user interaction with the display objectsuch that the user input value is communicated from the data interfaceto the processor for generating the estimate.

Some embodiments of the portable infusion device may be configured fordelivery of a fluid to a body of a user and may include a fluidinterface for receiving the fluid and a delivery mechanism foreffectuating the delivery of the fluid. In addition, the infusion devicemay include a processor that executes instructions for generating anestimate of an amount of the fluid for delivery. The infusion device mayfurther include a touch sensitive display configured for displaying atleast one display object such that user interaction with the displayobject generates a user input value. The infusion device may furtherinclude a data interface configured for receiving the user input valuefrom the touch sensitive display in response to user interaction withthe display object such that the received user input value iscommunicated from the data interface to the processor for generating theestimate.

Some embodiments of the portable infusion device are directed at amethod for delivering an amount of a fluid to a body of a user. Themethod may include receiving user interaction from a touch sensitivedisplay configured for displaying at least one display object, such thatuser interaction with the display object generates a user input value.The method may further include generating an estimate of an amount offluid to be delivered to the body in response to the user input value,and displaying a confirmation display object on the touch sensitivedisplay, such that the confirmation display object requests aconfirmation input from the user for confirmation before delivery of theamount of fluid to the body of the user. The method may further includeinitiating delivery of the fluid in response to receiving theconfirmation input.

Some embodiments of the system for generating an estimate of an amountof fluid to be delivered to a body and delivering the amount of fluid tothe body of a user in accordance with the generated estimate may includea remote commander. The remote commander may include a displayconfigured for displaying at least one display object, such that thedisplay object indicates a value such that user interaction with thedisplay object generates a user input value. The remote commander mayfurther include a data interface configured for receiving the user inputvalue from the display in response to user interaction with the display,and a processor that receives the user input value from the datainterface and generates an estimate of the amount of fluid to bedelivered to the body. Furthermore, the processor may provide theestimate to the data interface for display of the estimate on thedisplay. The processor may further generate an infusion command inresponse to receiving a confirmation input from the data interface. Inaddition, the confirmation input may include a user interaction with thedisplay in response to display of a confirmation display object on thedisplay, such that the confirmation display object requests aconfirmation input from the user for confirmation before delivery of theamount of fluid to the body of the user. The remote commander mayfurther include a transmitter that transmits the infusion command, withthe infusion command comprising an instruction for delivery of theamount of the fluid in accordance with the generated estimate andconfirmation input. The system may further include an infusion device.The infusion device may include a fluid interface configured forreceiving the fluid, a delivery mechanism configured for effectuatingthe delivery of the fluid, and a receiver configured for receiving theinfusion command from the transmitter of the remote commander. Inaddition, the system may include a processor that receives the infusioncommand from the receiver and initiates delivery of the amount of thefluid from the fluid interface to the body of the user in accordancewith the generated estimate.

Some embodiments of the system may facilitate instructing a user on howto operate a portable infusion device. The system may include a touchsensitive display configured for displaying at least one display object,such that user interaction with the touch sensitive display generates auser input value. In addition, the system may include a processorfunctionally linked to the touch sensitive display and configured forreceiving the user input value. The system may further include a programfile for execution by the processor, which may include datacorresponding to an arrangement of at least one of a text and a graphic,such that when the program file is executed by the processor the atleast one of the text and graphic is displayed on the touch sensitivedisplay and provides information to the user about operation of theportable infusion device. In addition, at least one of the text andgraphic displayed on the touch sensitive display may be animated.Furthermore, the processor may execute the program file in response tothe user input value corresponding to a request for the information.

Some embodiments of the device may be directed at a method of providinginformation to a user of a portable infusion device. The method mayinclude displaying at least one display object on a touch sensitivedisplay of the portable infusion device. In addition, the at least onedisplay object may relate to at least one of a text and a graphicproviding information to the user about the portable infusion device.The method may also include the portable infusion device detecting userinteraction with the touch sensitive display and being responsive to thedetected user interaction. In addition, the method may include animatingat least one display object displayed on the touch sensitive display.

Some embodiments of the system for facilitating user error prevention ofa portable infusion device may include a touch sensitive displayconfigured for displaying at least one display object. In addition, thetouch sensitive display may be configured such that user interactionwith the display generates a user input value. The system may furtherinclude a processor functionally linked to the display and configuredfor receiving the user input value and processor instructions that areaccessible by the processor and are configured to instruct the processorto execute a number of tasks. In addition, some tasks may includedisplaying a plurality of objects on the touch sensitive display suchthat the plurality of objects include at least two objects, each ofwhich represents a different user input value. Furthermore, processortasks may include receiving a user selection of one displayed object andcorresponding it to a represented user input value. Additionally,processor tasks may include ignoring the received user selection if therepresented user input value is not an acceptable value for operation ofthe portable infusion device, and otherwise accept the received userselection as a user input value for operation of the portable infusiondevice.

Some embodiments may be directed at a method of using a portableinfusion device for facilitating user error prevention. The method mayinclude displaying a plurality of objects on a touch sensitive displayof the portable infusion device, such that the plurality of objectsincluding at least two objects where each of which represents adifferent user input value. Additionally, the method may includereceiving a user selection of one displayed object on the touchsensitive display, such that the user selection corresponding to arepresented user input value. Furthermore, the method may includeignoring the received user selection if the represented user input valueis not an acceptable value for operation of the portable infusiondevice, and otherwise accepting the received user selection as a userinput value for operation of the portable infusion device.

Some embodiments may include a portable infusion device, which mayinclude a processor and a touch screen display functionally linked tothe processor and having a display area that operates as a touch inputarea that detects user interaction therewith. In addition, the portableinfusion device may include a plurality of modifiable objects displayedon the touch screen display, such that the plurality of modifiableobjects representing various information may be simultaneously displayedin the touch input area of said touch screen display. Additionally, thetouch screen display and processor may respond to a user touch to anyone of said modifiable objects on the touch screen display for at leastone of viewing, inputting, and modifying information associated with theobject touched by said user.

Some embodiments of the device may further include a memory forreceiving and storing user input data which memory is coupled to theprocessor and is configured for communicating that data to theprocessor.

Some embodiments of the device may additionally include a display suchas a display that is configured for displaying a request for a user toinput data. The display may further be configured for receiving userinput data in response to the request and communicating that data to thememory. The display may additionally be configured for displaying arequest for additional user interaction prior to delivering the fluid tothe body. The request for additional user interaction includes one ormore of an acceptance of delivery, a rejection of delivery, or a requestfor more information.

In certain instances, device embodiments may include a reservoir forstoring a fluid such as insulin to be delivered to a body of a user anda delivery mechanism, for effecting the delivery of the fluid. In suchan embodiment, the processor may further be configured for controllingone or both of the delivery mechanism and reservoir in accordance withthe generated estimate of the amount of fluid to be delivered to thebody.

Some embodiments are directed to a method for delivering an amount of afluid to a body of a user. The method may include providing an infusiondevice such as a device described above having at least a data inputinterface, a processor, and a display. The method may further includeinputting externally supplied values into the data input interface,wherein the data input interface receives the user input data andcommunicates that data to the processor, the processor receives the userinput data, generates an estimate of an amount of a fluid to bedelivered to the body of the user, and communicates the estimate to thedisplay. The method may additionally include receiving the generatedestimate of an amount of fluid to be delivered on the display of thedevice and receiving a request for a user input on the display of thedevice. Furthermore, the request may require the user to make aselection before delivering the amount of fluid to the body of the userand making a selection based on the estimate so that once the selectionis made, the device delivers the quantity of fluid to the body inresponse to the selection. The user input data includes one or more of ablood glucose level, a stress level, a physiological condition, acomplexity of a meal to be ingested, an activity level, user history,and the like.

Some embodiments are directed to a system for generating an estimate ofan amount of fluid to be delivered to a body and delivering the amountof fluid to the body of a user in accordance with the generatedestimate. The system may include a remote commander, which may includeone or more of a processor for generating an estimate of an amount offluid to be delivered to a body in response to user input data, and adata input interface for communicating with the processor. Furthermore,the data input interface may be configured for receiving user inputdata. The system may further include a memory coupled to the processorfor receiving and storing user input data, a display for displaying theestimate of an amount of a fluid to be delivered, and/or a transmitterfor transmitting a command to an infuser device. In addition, thecommand may instruct the infuser device to deliver an amount of fluid inaccordance with the generated and confirmed estimate. The system mayfurther include an infuser device, such as one described above,configured for delivering an amount of a fluid to be delivered to a bodyof a user in accordance with a generated estimate. For instance, thedevice may include a reservoir, for storing the fluid, a deliverymechanism for effectuating the delivery of the fluid, a receiver forreceiving the command from the transmitter of the remote commander, anda processor for instructing the reservoir and delivery mechanism todeliver the amount of fluid to the body of a user in accordance with thegenerated estimate. In an additional aspect, the disclosure is directedto a kit including one or more of an infusion device and/or a remotecommander, as described above, and instructions for using the same.

Certain embodiments are described further in the following description,examples, claims and drawings. These features of embodiments will becomemore apparent from the following detailed description when taken inconjunction with the accompanying exemplary drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an embodiment of an interchangeable pump assembly.

FIG. 2 illustrates an embodiment of a full-featured pump device havingan infusion cartridge coupled thereto.

FIG. 3 illustrates a block diagram representing an example of afull-featured pump device.

FIG. 4 illustrates an embodiment of a basic pump device having aninfusion cartridge coupled thereto.

FIG. 5 illustrates a block diagram representing an example of a pumpdevice incorporating basic features.

FIG. 6 illustrates an embodiment of an interchangeable infusioncartridge.

FIG. 7A shows a rear view of a full featured infusion pump having a slotconfigured to receive an infusion cartridge or glucose meter.

FIG. 7B shows a rear view of a basic infusion pump having a slotconfigured to receive an infusion cartridge or glucose meter.

FIG. 7C shows a rear view of the full featured infusion pump of FIG. 7Awith an infusion cartridge disposed in the slot.

FIG. 7D shows the basic infusion pump of FIG. 7B with a glucose meterdisposed in the slot of the basic infusion pump.

FIG. 8 illustrates an embodiment of a removable glucose meter andassociated glucose test strip.

FIG. 9A is a front view in perspective of an embodiment of a fullfeatured infusion pump system.

FIG. 9B is a rear view of an infusion cartridge coupled to the infusionpump device of FIG. 9A.

FIG. 9C is a rear schematic view of an interior of the infusion pump andcartridge embodiments of FIG. 9A.

FIG. 9D illustrates an embodiment of an infusion pump system inoperative communication with a patient.

FIG. 9E illustrates an enlarged view in partial section of a distal endof an infusion line of the infusion pump system of FIG. 9D disposedsubcutaneously in the patient.

FIG. 10 illustrates an exploded view of the infusion cartridge and pumpdevice of FIG. 9.

FIG. 11 illustrates a section view of an attachment mechanism of theinfusion cartridge and pump device of FIG. 9.

FIG. 12A illustrates in section an interface between embodiments of aspool of the delivery mechanism and drive mechanism of the infusion pumpof FIG. 9.

FIGS. 12B-12D illustrate interface embodiments of the bore of the spooland ball feature embodiments.

FIG. 13 illustrates an alignment mechanism embodiment of the infusionpump embodiment of FIG. 9.

FIG. 13A illustrates a flared rail embodiment of the pump housing andreservoir cartridge.

FIG. 14 is a section view of the delivery mechanism embodiment shown inFIGS. 12A and 12B with the spool of the delivery mechanism positioned ata distal hard stop for filling of the expandable reservoir.

FIG. 14A is a transverse section view of the delivery mechanism of FIG.14 taken along lines 14A-14A of FIG. 14.

FIG. 14B is a transverse section view of the delivery mechanism of FIG.14 taken along lines 14B-14B of FIG. 14.

FIG. 14C is a transverse section view of the delivery mechanism of FIG.14 taken along lines 14C-14C of FIG. 14.

FIG. 14D is a transverse section view of another embodiment of thedelivery mechanism of FIG. 14 taken along lines 14C-14C of FIG. 14.

FIG. 14E is a transverse section view of another embodiment of thedelivery mechanism of FIG. 14 taken along lines 14C-14C of FIG. 14.

FIG. 15 is a section view of the delivery mechanism embodiment of FIGS.12A and 12B with the spool of the delivery mechanism positioned forfilling of a collapsible volume of the spool.

FIG. 15A is a section view of the delivery mechanism embodiment of FIGS.12A and 12B with the spool of the delivery mechanism positioned afterfilling of the collapsible volume of the spool.

FIG. 15B shows the spool of FIG. 15A with the collapsible volume of thedevice full of fluid being displaced proximally towards the dispenseport of the device.

FIG. 16 is a section view of the delivery mechanism embodiment of FIGS.12A and 12B with the spool of the delivery mechanism positioned prior todelivery of fluid into the dispense port from the collapsible volume ofthe spool.

FIG. 17 is a section view of the delivery mechanism embodiment of FIGS.12A and 12B with the spool of the delivery mechanism positioned afterdelivery of fluid from the collapsible volume of the spool into thedispense port.

FIG. 18 is a section view of the delivery mechanism embodiment of FIGS.12A and 12B with the spool of the delivery mechanism positioned prior todelivery of fluid from the expandable volume of the spool and with avent channel established for the vented volume of the cartridge.

FIG. 19A is a section view of a delivery mechanism embodiment having anexpandable volume formed from a sliding seal and with a spool of thedelivery mechanism positioned prior to delivery of fluid from theexpandable volume of the spool with a vent channel remaining closed.

FIG. 19B is a section view of the delivery mechanism embodiment of FIG.19A with the spool of the delivery mechanism positioned after deliveryof fluid from the expandable volume of the spool.

FIG. 19C is a section view of the delivery mechanism of FIG. 19B brokenaway for purposes of illustration.

FIG. 19D is a transverse section view of the delivery mechanism of FIG.19C taken along lines 19D-19D of FIG. 19C.

FIG. 19E is a transverse section view of the delivery mechanism of FIG.19C taken along lines 19E-19E of FIG. 19C.

FIG. 20 is a block diagram representing an exemplary infusion pumpdevice.

FIG. 21 is a block diagram representing an exemplary delivery mechanismof an infusion pump embodiment.

FIG. 22 is a block diagram representing an reservoir embodimentassociated with an infusion pump embodiment.

FIG. 23 is a block diagram representing functioning of a processorembodiment of an infusion pump.

FIG. 24 is a block diagram representing a display of an infusion pumpembodiment.

FIG. 25 is a block diagram representing functioning of a processor of aninfusion pump embodiment.

FIG. 26 is an embodiment of information architecture representing a partof a GUI page or screen hierarchy of portable infusion deviceembodiments discussed herein.

FIG. 27 is an embodiment of a screen shot of a home screen page of theGUI page hierarchy of the portable infusion device.

FIG. 28 illustrates an embodiment of a bolus object.

FIG. 29 is a flow diagram illustrating a method of programming thedelivery of a bolus.

FIG. 30 is an embodiment of a bolus confirmation page of the GUI pagehierarchy.

FIG. 31 is a screen shot of a virtual keypad displayed on the touchscreen display for data entry.

FIG. 32 is a screen shot of an embodiment of an extended bolus setuppage.

FIG. 33 is a screen shot of an embodiment of an extended bolusconfirmation page.

FIG. 34 is a screen shot of an embodiment of a virtual keypad employinga dynamic error prevention feature.

FIG. 35 is a screen shot of an embodiment of a virtual keypad displayedon the touch screen display for entering text.

FIG. 36 is a screen shot of a home screen page embodiment.

FIG. 37 is a screen shot of a home screen page embodiment.

FIG. 38 is a screen shot of a home screen page embodiment.

FIG. 39 is a screen shot of a home screen page embodiment.

FIG. 40 is an enlarged view of a status indicator object displayed on apage of the GUI page hierarchy.

FIG. 41 is a screen shot of an options page embodiment.

FIG. 42 is a flow diagram of a delivery setup process embodiment for aportable infusion pump.

FIG. 42A is a screen shot of a data entry page embodiment for creationof a delivery profile.

FIG. 42B is a screen shot of a basal rate setup page embodiment forcreation of a delivery profile.

FIG. 42C is a screen shot of a basal confirmation page embodiment forcreation of a delivery profile.

FIG. 42D is a screen shot a blood glucose correction factor setup pageembodiment.

FIG. 42E is a screen shot of a blood glucose correction factorconfirmation page embodiment.

FIG. 42F is a screen shot of a blood glucose target correction setuppage embodiment.

FIG. 42G is a screen shot of a target blood glucose confirmation pageembodiment.

FIG. 42H is a screen shot of an insulin duration data entry pageembodiment.

FIG. 42I is a screen shot of a food bolus set up page embodiment.

FIG. 42J is a screen shot of a carbohydrate (carb) ratio set up pageembodiment.

FIG. 42K is a screen shot of a carb ratio confirmation page embodiment.

FIG. 42L is a screen shot of a quick bolus data entry page embodiment.

FIG. 43 is a flow chart of quick bolus set up process embodiment.

FIG. 43A is a screen shot of a quick bolus data entry page embodiment.

FIG. 43B is a screen shot of a quick bolus data entry page embodiment.

FIG. 43C is a screen shot of a quick bolus quick bolus data entryconfirmation/delay page embodiment.

FIG. 43D is a screen shot of a bolus confirmation page embodiment.

FIG. 44 is a screen shot of a blood glucose status page embodiment.

FIG. 45 is a screen shot of an instructional page embodiment for set upof a portable infusion pump.

FIG. 46 is a screen shot of an instructional page embodiment for set upof a portable infusion pump.

FIG. 47 is a screen shot of an instructional page embodiment for set upof a portable infusion pump.

FIG. 48 is a screen shot of a delivery profile time segment setup pageembodiment.

FIG. 49 is a screen shot of a delivery profile time segment confirmationpage embodiment.

FIG. 50A is a screen shot of a delivery calculation page embodiment.

FIG. 50B is a screen shot of a person settings page embodiment.

FIG. 51 is a screen shot of another embodiment of a home screen page.

FIG. 52 is a screen shot of another embodiment of a home screen page.

FIG. 53A is a screen shot of another embodiment of a bolus set up page.

FIG. 53B is a screen shot of another embodiment of a bolus set up page.

FIG. 53C is a screen shot of another embodiment of an extended bolus setup page.

FIG. 54 illustrates a screen which displays multiple graphssimultaneously on a touch screen display.

FIG. 55 illustrates a screen which displays multiple graphssimultaneously on a touch screen display.

The drawings illustrate embodiments of the technology and are notlimiting. For clarity and ease of illustration, the drawings may not bemade to scale and, in some instances, various aspects may be shownexaggerated or enlarged to facilitate an understanding of particularembodiments.

DETAILED DESCRIPTION

As discussed above generally, there is a need for an infusion devicethat is capable of taking into account factors in determining anappropriate amount of medicament (e.g., insulin) to be delivered to thebody so as to achieve blood glucose homeostasis. Medicament infuserembodiments are discussed herein that are configured in hardware,software, and/or user interface so as to receive user input and/or otherdata, which may be input by the users interaction with an intuitive userinterface, processed to determine an estimate of an amount and/or rateof medicament delivery, which estimate may then be accepted, rejected,or manipulated by the user, so as to effectuate the delivery of theappropriate amount of medicament and thereby maintain homeostasis.

Some infusion device, system, and the method embodiments discussedherein may account for a wide range of variables in determining anamount of medicament, e.g., insulin, to be infused into a patient over agiven period of time. Further, some embodiments discussed herein mayallow for fine regulation of the amount of medicament delivered as wellas the time during which the medicament is delivered. Some embodimentsmay include advances both in the internal components and the controlcircuitry as well as improvements in a user interface. The advances mayallow for a more fine tuned regulation of blood glucose levels than iscurrently attainable by the devices, systems, and methods that areavailable at this time. Although embodiments described herein may bediscussed in the context of the controlled delivery of medicaments suchas insulin, other indications and applications are also contemplated.Device and method embodiments discussed herein may be used for painmedication, chemotherapy, iron cleation, immunoglobulin treatment,dextrose or saline IV delivery, or any other suitable indication orapplication. Non-medical applications are also contemplated.

Maintaining appropriate blood glucose homeostasis is an important factorfor promoting the length and quality of life of a diabetic patient.Different types of pumps provide a user with various advantages, some ofwhich can be mutually exclusive. For example, a pump device having alarge output display can be easier to read and use compared to a pumpdevice with a smaller output display. But that pump may also have ahousing that is generally larger and may require a greater power usage.Large and bulky pump devices can be uncomfortable or unwieldy which cancontribute to problems with user compliance. For example, a user may beless likely to wear a larger pump device while sleeping or when involvedin certain activities. Smaller and more discreet pump systems known inthe art can be more easily worn at night, but do not provide all thefeatures patients have come to rely upon for safety and convenience. Andonce removed from the skin, known pump devices and their associatedinsulin cartridges cannot be used again.

A single insulin infusion cartridge can be used with a pump device tosupply a user with insulin over an extended period of days, such as 3days. During this time period a user's needs with respect to pumpfeatures can change. As mentioned above, full-featured pumps offercertain advantages that a user may not desire at other times such asduring sleep or busy weekend activities. Because known insulincartridges and infusion sets are not interchangeable they cannot be usedagain once the sterile field is broken and the infusion set andcartridge is used with one pump device. Known infusion sets and insulincartridges must be thrown out once they are disconnected from a patient.

Provided herein is an interchangeable pump assembly that provides a userwith the flexibility and convenience to alternate between pump deviceshaving various features and advantages at any given moment during asingle treatment protocol. In some cases a single insulin cartridge canbe alternated between pump devices, such as a smaller, more discreetpumping device having fewer features and a larger, full-featured pumpingdevice, during a single treatment without compromising the sterility,and thus wasting the cartridge.

Turning now to the figures, FIG. 1 shows an embodiment ofinterchangeable infusion assembly 10. The assembly 10 can include afirst pump device 12, a second pump device 14, an infusion cartridge 16having an infusion set connector 18, and optionally a glucose meter 20.Either the infusion cartridge 16 or the glucose meter 20 can befunctionally and interchangeably inserted in a receiving slot 22 locatedin the first pump 12 and a receiving slot 24 located in the second pump14, as will be discussed in more detail below. The first pump 12 canhave a housing 26 that is generally larger than the housing 28 of thesecond pump 14 (see also FIGS. 2 and 4). Similarly, the first pump 12generally includes more features than the second pump 14, as will bediscussed in more detail below. It should be noted that some or all ofthe suitable features, dimensions, materials and methods of use of theinfusion assembly 10 may be used or incorporated into any other infusionsystem, or components thereof, discussed herein. It should also be notedthat the interchangeability of infusion cartridge embodiments isdiscussed herein generally in the context of transferring an infusioncartridge from a first pump to a second pump having features differentfrom those of the first pump. However, all of the interchangeabilityfeatures and methods associated with this type of transfer may also beapplied to the transfer of an infusion cartridge from a first pump to asecond pump having the same features as the first pump.

FIG. 3 illustrates a block diagram of some of the features that can beincorporated within the housing 26 of the first pump 12. The first pump12 can include a memory device 30, a transmitter/receiver 32, an alarm34, a speaker 36, a clock/timer 38, an input device 40, a processor 42,an output/display 44 such as a graphic user interface or GUI having aninput 46, a drive mechanism 48, and an estimator device 50. Asmentioned, the housing 26 of the first pump 12 may be functionallyassociated with an interchangeable and removable glucose meter 20 orinfusion cartridge 16. The infusion cartridge 16 may have an outlet port52 that may be connected to an infusion set connector 18 and an infusionset 54.

FIG. 5 illustrates a block diagram of features that can be incorporatedwithin the more basic, second pump device 14. The second pump device 14can include memory 56, transmitter/receiver 58, processor 60,output/display 62, and drive mechanism 64. The housing 66 of the secondpump device 14 can be functionally associated with interchangeable andremovable glucose meter 20 or infusion cartridge 16. The infusioncartridge 16 can have an outlet 52 that can be connected to an infusionset connector 18 and an infusion set 54.

Variations of the pump devices and features described herein may exist.For example, the full-featured pump device 12 may include a number offeatures that may or may not be included in the basic pump device 14.The features of each of the pump devices may vary and one or both pumpdevices may include certain features that are described herein. Forexample, although the full-featured pump device 12 may be described inan embodiment as having a metal housing 26, the full featured pump 12may also have a plastic housing 26. Conversely, although the more basicpump device 14 may be described in an embodiment as having a plastichousing 28 it should be appreciated that it can also have a metalhousing 28. In general, the full-featured pump device embodiments 12described herein may include features that ultimately account for thedifference in size and weight compared to the basic pumping device 14.It should be appreciated that because a feature or characteristic isdescribed herein as being present on the full-featured pump device 12,that same feature or characteristic is not necessarily missing ordifferent on the more basic pump device 14. The description belowprovides examples of some of the features that may be incorporated intoone or both of the full-featured pump device 12 and the basic pumpdevice 14.

The housing 26 of the first pump device 12 (see FIG. 2) and the housing28 of the second pump device 14 (see FIG. 4) can each be of any suitableshape and size. For instance, the housings 26 and 28 may be extended andtubular, or in the shape of a square, rectangle, circle, cylinder or thelike. The housings 26 and 28 may be dimensioned so as to be comfortablyassociated with a user and/or hidden from view, for instance, within theclothes of a user. The housing 26 of the first pump device 12 maygenerally be larger than the housing 28 of the second pump device 14. Insome embodiments, the housing 26 of the full-featured pump device 12 mayhave a width of about 2 inches to about 5 inches, a height of about 1inch to about 3 inches and a thickness of about 0.25 inch to about 0.75inch, more specifically, the housing 26 may have a width of about 2.5inches to about 3.5 inches, a height of about 1.5 inches to about 2.5inches and a thickness of about 0.4 inches to about 0.8 inches. For someembodiments, the housing 28 of the basic pump device 14 may have a widthof about 2.5 inches to about 3.5 inches, a height of about 1 inch toabout 2 inches and a thickness of about 0.2 inches to about 0.6 inches.The materials of the housings 26 and 28 may vary as well. In someembodiments, housing of the full-featured pump device 12 may be awater-tight, metal housing that may be taken apart for repairs. In someembodiments, housing 28 of the basic pump device 14 may be a verywater-tight, plastic housing that is glued together permanently.

Still with respect to FIGS. 2 and 4, the pump devices 12 and 14 mayinclude an output/display 44 or 62. The type of output/display 44 or 62may vary as may be useful for particular application. The type of visualoutput/display may include LCD displays, LED displays, plasma displays,OLED displays and the like. The output/display 44 or 62 may also be aninteractive or touch sensitive screen having an input device such as atouch screen, a capacitance screen, a resistive screen or the like. Theoutput/display 44 of the first pump device 12 may be generally largerthan the output/display 62 of the second pump device 14. In someembodiments, the output/display 44 of the full-featured pump device 12may be an OLED screen and the input 40 may be a capacitance touchscreen. In some embodiments, the output/display 62 of the basic pumpdevice 14 may be an LCD screen. The pump devices 12 and 14 mayadditionally include a keyboard or other input device known in the artfor data entry, which may be separate from the display. Theoutput/display 44 or 62 of the pump devices 12 or 14 may also include acapability to operatively couple to a secondary display device such as alaptop computer, mobile communication device such as a smartphone orpersonal digital assistant (PDA) or the like.

The pump devices 12 or 14 may have wired or wireless communicationcapability such as for the sending and receiving of data as is known inthe art. The wireless capability may be used for a variety purposes,including updating of any software or firmware for the processor of thedevice. The wireless communication capability may vary including, e.g.,a transmitter and/or receiver, radiofrequency (RF) transceiver, WIFIconnection, infrared or Bluetooth® communication device. The wiredcommunication capability may also vary including, e.g., USB or SD port,flash drive port, or the like. In some embodiments, the first pumpdevice 12 and the second pump device 14 each has a transmitter/receiver32, such as a radiofrequency (RF) transceiver, that allows the first andsecond pump devices 12 and 14 to communicate with one another and beused interchangeably without loss of data or information during aninfusion protocol with a single infusion cartridge 16. A user canalternate between the full-featured first pump device 12 and the morebasic, second pump device 14 during a single infusion protocol and thetransfer of data between the two can be automatic. The first pump device12 may also act as a PDA or controller to wirelessly control the secondpump device 14. For such an embodiment, data may be transferred betweenthe controller of the first pump device and second pump device by radiosignal, optical transmission or any other suitable means. Both the firstand second pump devices 12 and 14 may be used as stand-alone devices aswell.

One or more of the pump devices 12 or 14 may also include GPSfunctionality, phone functionality, warning and/or alarm programming;music storage and replay functionality, e.g., an MP3 player; a camera orvideo mechanism; auto scaling capabilities, and/or one or more videotype games or other applications developed by third parties for usethereon. One or more of the pump devices 12 or 14 may also include anaccelerometer, for instance, which may be used for changing presentedestimates, wherein instead of scrolling through a menu of options orusing a numerical keypad, values can be input or changed via theaccelerometer, such as by gesturing with or otherwise shaking thedevice.

As shown in FIGS. 3 and 5 the first and second pump devices 12 and 14each has a processor 42 and 60 that functions to control the overallfunctions of the device. The processors 42 and 60 may includeprogramming that functions to control the respective device and itscomponents. The processors 42 and 60 may communicate with and/orotherwise control the drive mechanism, output/display, memory,transmitter/receiver and the like. The processor of one of the pumpdevices may communicate with the processor of the other pump device, forexample, through the transmitter/receiver. The processors may includeprogramming that can be run to control the infusion of insulin or othermedicament from the cartridge, the data to be displayed by the display,the data to be transmitted via the transmitter, etc. The processors mayalso include programming that allows the processors to receive signalsand/or other data from an input device, such as a sensor that sensespressure, temperature, and the like, that may be included as a part ofthe device or used in conjunction therewith. The processors 42 and 60may receive signals, for instance, from a transmitter/receiver on theblood glucose monitor (see FIG. 8) and store the signals in the memory,as will be discussed in more detail below.

The processors 42 and 60 may also include additional programming toallow the processor to learn user preferences and/or usercharacteristics and/or user history data, for instance, to implementchanges in use suggestions based on detected trends, such as weight gainor loss; and may include programming that allows the device to generatereports, such as reports based upon user history, compliance, trending,and/or other such data. Additionally, pump device embodiments of thedisclosure may include a “power off” or “suspend” function forsuspending one or more functions of the device, such as suspending adelivery protocol, and/or for powering off the device or the deliverymechanism thereof. For some embodiments, two or more processors may beused for controller function of the pumps, including a high powercontroller and a low power controller used to maintain programming andpump functions in low power mode in order to save battery life.

The first pump device 12 and the second pump device 14 may each includea memory device 30 and 56. The memory devices 30 and 56 may be any typeof memory capable of storing data and communicating that data to one ormore other components of the device, such as the processor. The memorymay be one or more of a Flash memory, SRAM, ROM, DRAM, RAM, EPROM,dynamic storage, and the like. For instance, the memory may be coupledto the processor and configured to receive and store input data and/orstore one or more template or generated delivery patterns. For example,the memory can be configured to store one or more personalized (e.g.,user defined) delivery profiles, such as a profile based on a user'sselection and/or grouping of various input factors (as described below);past generated delivery profiles; recommended delivery profiles; one ormore traditional delivery profiles, e.g., square wave, dual square wave,basal and bolus rate profiles; and/or the like. The memory can alsostore user information, history of use, glucose measurements,compliance, an accessible calendar of events, and the like. The firstpump device 12 may have a relatively large memory compared to the memoryof the second pump device 14. In some embodiments, the memory 30 of thefirst pump device 12 may be up to about 10 GB, more specifically, up toabout 3 GB, even more specifically, about 1 MB to about 200 MB. In someembodiments, the memory 56 of the second pump 14 may be up to about 3GB, more specifically, up to about 500 MB, and even more specifically,about 200 kB to about 200 MB.

The first and second pump devices 12 and 14 may include a power chargingmechanism in some cases, such as a USB port, induction charger, or thelike. The power charging system may be used to charge a power storagecell such as a rechargeable battery of the pump device. Some embodimentsmay use a rechargeable battery such as a NiCad battery, LiPo battery,NiMH battery or the like. In some embodiments, the power chargingmechanism 68 of the first pump 12 may be a USB port. As such, all datamay be kept in the first pump device 12 for quick and easy downloadingof data to a computer, other pump device, network etc. using the USBport. The USB port 68 of the first pump device 12 may also provide thefirst pump device 12 with power charging. In some instances, the powercharging mechanism 70 of the second pump device 14 may be an inductioncharging device. In some cases, an advantage of having interchangeablepumping devices 12 and 14 may be that while one pump device is beingused for infusion, the other pump device can be charging. Further, theuse of dual pump devices may provide a user of the pumps with a back-upin case of failure of one pump device.

The first pump 12 may also include programming to allow processor 42 tomake a recommendation regarding a variety of treatment parameters. Forinstance, the processor 42 may include one or more estimatorfunctionalities 50, which may allow the processor 42 to receive datafrom various sources, parse the data, collate the same, and generate anestimate based on the same. For instance, the processor 42 may receiveuser input data and/or data from one or more sensors or other externalsources, which the processor 42 can process and thereby use to generatean estimate, such as an estimate of an amount of fluid to deliver to abody, a rate of fluid delivery, and/or a specific fluid deliveryprofile. For example, the processor 42 may be configured to process datapertinent to a current or predicted condition and to generate anestimate, represented as an amount, rate, profile, etc. of fluid to bedelivered based on that data, which estimate may then be displayed to auser, thereby allowing the user to interact with the estimate to accept,decline, and/or otherwise modify the estimate.

FIG. 6 shows an embodiment of the infusion cartridge 16. The infusioncartridge 16 may include a housing 72 having an inner chamber 74containing a fluid reservoir that can store, for example liquid insulinor other suitable medicament. The fluid reservoir 76 may have anysuitable shape and size configured for receiving fluid through a fillport 134 (see FIG. 10), storing the fluid and releasing the fluid. Thefluid reservoir 76 may be an expandable bag. In some embodiments, thefluid reservoir 76 may be a bag or container surrounded or formed by aflexible material 80 that may be expandable, but not elastic orstretchy. In some embodiments, the fluid reservoir 76 may be filled suchthat the fluid reservoir occupies approximately ¾ of the volume of aninner chamber 74 of the housing 72. In these embodiments, the remaining¼ of the inner chamber 74 of the housing 72 may hold or store a gas suchas air, carbon dioxide or the like. The fluid reservoir 76 and the innerchamber 74 may store their respective fluids under pressure, such asatmospheric, a pressure higher than atmospheric pressure or a pressurelower than atmospheric or ambient pressure.

Still with respect to FIG. 6, the infusion cartridge 16 may be areversibly removable and interchangeable element that can be inserted ineither the receiving slot 22 of the first pump device 12 or thereceiving slot 24 of the second pump device 14. Each of the pumphousings 26 and 28 may include an alignment and attachment mechanism(see FIGS. 7A and 7B) corresponding to a receiving mechanism 84 on thecartridge 16. The receiving mechanism 84 may couple with the attachmentmechanism 82 such that the infusion cartridge 16 may be reversiblyattached and detached from the housings 26 and 28 of the pump devices 12and 14 for fluid delivery as will be discussed in more detail below. Thealignment and attachment mechanism 82 may also include a needle 86 thatpenetrates a septum 88 on the end of the infusion cartridge 16.

As shown in FIGS. 7A and 7B, the needle 86 may be positioned betweenpins of the attachment mechanism 82 such that the pins of the attachmentmechanism 82 act to align the cartridge 16 to ensure proper insertion ofthe needle 86 through the septum 88 (shown in FIG. 6). The needle 86 canpenetrate the septum 88 upon installation of the infusion cartridge 16in the slot 22 such that the inner chamber 74 of the infusion cartridge16 may be in sealed communication with the pump device 12. In someinstances, the septum 88 may be a self-sealing septum such that uponremoval of the cartridge 16 from the slot 22 and the needle 86 throughthe septum 88, the septum re-seals. The configuration of the receivingmechanism and corresponding attachment mechanism 82 may vary in someinstances. For example, the mechanisms may be a pin and receiver porttype of mechanism as shown in FIGS. 7A and 7B or a pneumatic tap systemas will be described in more detail below.

Now with respect to FIGS. 7C and 7D, the infusion cartridge 16 may alsoinclude a delivery mechanism 90 that functionally and operablyinterfaces with the drive mechanism 92 of the pump devices 12 and 14.The infusion cartridge 16 and the pump devices 12 and 14 may bereversibly attached and detached to each other regardless of the stageof treatment or the position of the drive mechanism 92. The drivemechanism 92 regulates the flow of fluid from the reservoir outwardsthrough the outlet 52. In some embodiments, the inner chamber 74 mayinclude an opening 52 that fluidly communicates with the deliverymechanism 90 and may allow the fluid stored within the reservoir 76 tobe expelled from the reservoir 76 through the opening 52 into thedelivery mechanism 90 upon control of a valve or other mechanism.Ultimately the fluid can be expelled through outlet 52 towards theinfusion set connector 18 and to the user. The drive mechanism 92 may bean electrically powered drive mechanism 92 as translated by a gear orreduction system. For some embodiments, the drive mechanism 92 mayinclude a hydraulic mechanism, pneumatic mechanism, piezoelectricmechanism, stepper motor, continuous motor, or the like. In someembodiments, the drive mechanism 92 may include a rack and pinion systemin which the rack upon rotation of the pinion moves laterally within atranslation chamber of the delivery mechanism.

As mentioned above, the attachment mechanism 82 may act as an alignmentdevice to ensure proper insertion of the needle 86 through the septum 88and proper coupling of the delivery mechanism 90 with the drivemechanism 92. The infusion cartridge 16 and pump devices 12 and 14 mayinclude additional alignment mechanisms that ensure proper couplingoccurs to prevent inadvertent lateral translation and delivery ofinsulin or other medicament to the patient. For example, the pump device12 or 14 may also include a horse collar type device or other featurepositioned near a location where the delivery mechanism 90 couples tothe drive mechanism 92. Such a feature may prevent lateral movement ofthe infusion cartridge 16 (and in turn the delivery mechanism 90) forsome configurations as it couples with the pump device 12 and 14 suchthat inadvertent delivery of insulin to the patient upon insertion ofthe cartridge into the pump device is prevented. The head 94 of thecartridge 16 which contains the delivery mechanism 90 may also be heldusing a rail system as will be described in more detail below. A snapsystem including corresponding male and female parts that allow theinfusion cartridge 16 to snap into place in operable contact with thepump devices 12 and 14 may also be used.

Some embodiments of the pump assembly 12 or 14 may also include aremovable glucose meter 20 (FIG. 8). The glucose meter 20 may include ahousing 96 having an insert hole 98. A measuring probe or glucose teststrip 100 may be inserted into the insert hole 98. The glucose meter 20may include a control panel 102 configured to control and a measuringlamp 104. Alternatively, the glucose meter 20 may be controlled by theinput on the pump devices 12 or 14. The control panel 102 may alsoconvert a measured value from the measuring lamp 104 into a signal thatmay be transmitted and recognized by the processor 42 or 60 of the pumpdevice 12 or 14. The data may be transmitted wirelessly such as by atransmitter/receiver or may be a wired connection between the pumpdevice and the glucose meter 20 upon insertion into the receiving slot22 or 24. In some embodiments, the communication between the glucosemeter 20 and the pump device 12 or 14 occurs wirelessly by RF or thelike. Although the glucose meter discussed above utilizes a test stripfor testing, any other suitable glucose testing method or device may beused such as the use of optical methods or electrical methods.

As described above, each of the pump devices 12 and 14 may have areceiving slot 22 or 24 into which the infusion cartridge 16 or theglucose meter 20 may be inserted. Like the infusion cartridge 16, theglucose meter 20 may be a reversibly removable and interchangeableelement that can be inserted in either the receiving slot 22 of thefirst pump device 12 or the receiving slot 24 of the second pump device14. The housing 96 of the glucose meter 20 may have the same or similardimensions as the housing 72 of the infusion or reservoir cartridge 16and include the same attachment mechanism 84 as that of the cartridge16. As described above, each of the pump housings 26 and 28 may includean attachment mechanism 82 (see FIGS. 7A and 7B). The attachmentmechanism 84 of the glucose meter 20 may corresponding to the attachmentmechanism on the pump devices 12 or 14 such that the glucose meter 20may be removably coupled to the housings 26 or 28 of the pumps 12 or 14.The configuration of the attachment mechanisms may vary as describedabove. Embodiments of the glucose meter 20, once inserted into thereceiving slot 22 or 24, may communicate with the pump devices 12 and 14such that the results of the glucose meter, such as a glucose monitoringtest strip 100, may automatically be entered into the data log.

The glucose meter 20 may be inserted into the same receiving slot 22 or24 as the infusion cartridge 16. The assembly therefore may have theadded advantage of fewer devices for which the user must mind. Forexample, while the infusion cartridge 16 is inserted into the receivingslot 22 of the first pump device 12 and being used for a treatmentinfusion protocol, the glucose meter 20 may be inserted within thereceiving slot 24 of the second pump device 14 while that pump device 14is not being used or is charging. Thus, the receiving slot 22 or 24 ofthe pump device 12 or 14 not being actively used provides a storagelocation for the glucose meter 20 (see FIGS. 7C and 7D). Further, theassembly may have an advantage that the glucose meter 20 may be anynumber of different glucose meters made by a number of differentcompanies such that the user has the added flexibility to decide whichcompany's glucose meter and glucose test strips 100 they prefer to use.

FIGS. 9A-14 show another embodiment of an infusion pump system 110including an infusion cartridge 112 and pump device 114. As withpreviously described embodiments, the infusion cartridge 112 is areversibly removable and interchangeable element that may be insertedinto different pump devices. The pump device embodiment 114 may havesome or all of the same or similar features, dimensions or materials asthose of the pump devices 12 and 14 illustrated in FIG. 2. Referring toFIG. 9A, a front view of the pump device 114 is shown and includes auser friendly user interface 116 on a front surface 118 of the pumpdevice 114. The user interface 116 includes a touch sensitive screen 120that may be configured to display a variety of screens used fordisplaying data, facilitating data entry by a patient, providing visualtutorials, as well as other interface features that may be useful to apatient operating the pump device 114. FIG. 9B is a rear view of thepump device 114 and illustrates the detachable installment of theinfusion cartridge 112 in a slot 122 of the pump device 114 which isconfigured to accept the cartridge 112. FIG. 9C is a schematic view ofan open housing 124 of the pump device 114 which shows schematicallysome components that may be included in embodiments of the pump device114. FIG. 9D shows the pump system 110 operatively coupled to a patient127. FIG. 9E shows an outlet 123 of an infusion set 125 disposed beneaththe skin of a patient 127. The infusion set is in fluid communicationwith a dispense part at the pump system 110 and a fluid 121, such asinsulin or other suitable medicament, is shown being disposed form theoutlet 123 into the body of the patient 127. It should be noted thatsome or all of the suitable features, dimensions, materials and methodsof use of the infusion pump system 110 may be used or incorporated intoany other infusion system, or components thereof, discussed herein.

For some embodiments, the pump system 110 may include a disposable fluidreservoir cartridge 112. The disposable cartridge 112 may include afluid interface configured to receive a fluid such as collapsiblereservoir 126. The collapsible reservoir 126 may be formed from aflexible material or membrane 128 that is disposed about an interiorvolume of the reservoir 126. The cartridge 112 also includes asubstantially rigid container 130 sealed around the flexible material ofthe collapsible reservoir 126. A disposable delivery mechanism 132 isdisposed within the disposable cartridge 112 and may have a fill port134 with a re-sealable septum 136 sealed over the fill port 134, areservoir inlet port 138 in fluid communication with an interior volume140 of the collapsible reservoir 126, a fluid dispense port 142 in fluidcommunication with a bore 144 of the delivery mechanism 132, a ventinlet port 146 and a vent outlet port 148 both in fluid communicationwith the bore 144. The collapsible reservoir 126 may have a bag-likestructure with flexible walls that can collapse and expand dependingupon the amount of material in the volume of the reservoir. The interiorvolume of the reservoir may be in fluid isolation from the remaininginterior volume of the rigid container 130.

For some embodiments, the reservoir may be formed from a membrane havinga thickness of about 0.001 inches to about 0.005 inches, morespecifically, about 0.002 inches to about 0.004 inches. In some cases,the membrane of the reservoir may be made from polymers such as PET,SiO, linear low density polyethylene or the like. Some embodiments ofthe reservoir may have an interior volume in a fully expanded state ofabout 1 ml to about 10 ml, more specifically, about 3 ml to about 5 ml.The membrane of the reservoir 126 may have a generally enclosedconfiguration with a top portion in sealed relation to the housing ofthe delivery mechanism. The membrane may be sealed and bonded to thehousing of the delivery mechanism by heat welding, adhesive bonding orany other suitable method. The rigid container 130 of the cartridge mayhave an interior volume of about 2 to about 15 ml, more specifically,about 3 ml to about 5 ml. The shell 130 may be made from any suitablematerial, and particularly moldable materials, including polymers andspecific materials such as polycarbonate or the like. The shell may havea nominal wall thickness of about 0.03 inches to about 0.08 inches, morespecifically, about 0.04 inches to about 0.06 inches.

The cartridge 112 may be releasably and operatively secured to a housing124 of the pump device 114. The housing 124 may be configured to house adrive mechanism 150 including a motor 152 and gear box 154 disposed inthe housing 124 and detachably coupled to a spool member 156 of thedelivery mechanism 132. The drive mechanism 150 may be detachably andoperatively coupled to the spool 156 member of the delivery mechanism132. At least one pressure sensor 158 may be disposed in a volume 160between an outside surface 162 of the flexible material or membrane 128of the collapsible reservoir 126 and an inside surface 164 of thesubstantially rigid shell or case 130. As shown in FIG. 9C, a graphicuser interface 166 may be operatively coupled to a controller 168, whichmay include at least one processor 170, a memory device 172 andconnective circuitry or other data conduits that couple the datagenerating or data managing components of the device. A power storagecell in the form of a battery 174 that may be rechargeable may also bedisposed within the housing 124. Data generating or managing componentsof the device may include the processor(s) 170, the memory device 172,sensors 158, including any pressure or temperature sensors, the GUI 166and the like.

Other components such as the vibratory motor 175, speaker 178, battery174 and motor 152 of the drive mechanism 150 may also be operativelycoupled to the controller 168. Connective circuitry may includeconductive wiring such as copper wiring, fiber optic conduits, RFconduits and the like. For some embodiments, the fluid reservoircartridge 112, and any of the fluid reservoir cartridges discussedherein, may include an encoder or bar code type strip (not shown). Theencoder strip or device may be configured to be scanned and read by areader device of the pump 114 with the reader device in operativecommunication with the controller 168 or processor 170 thereof. Theencoder device may alternatively be an RFID chip or the like thattransmits data to a reader such as a data receiving processor or thelike. Such encoder device embodiments may include the ability tosecurely transmit and store data, such as, via, encryption, to preventunauthorized access or tampering with such data. The identification ofthe fluid reservoir cartridge 112 may be used by the controller 168 toset or to adjust certain dispense parameters or any other suitableparameters.

For the embodiment shown, the vent inlet port 146 may be disposed on thedelivery mechanism 132 in fluid communication with the volume 160disposed between the outside surface 162 of the flexible material ormembrane 128 of the collapsible reservoir 126 and an inside surface 164of the substantially rigid shell or case 130 of the infusion cartridge.The controller 168 may include at least one processor 170 and a memorydevice 172, the controller 168 being operatively coupled to the drivemechanism 150, GUI 166, and at least one pressure sensor 158. Thecontroller may be configured to generate a signal to the drive mechanism150 to displace the spool 156 of the delivery mechanism 132.

As shown in FIGS. 10-11, the pump device 114 may include an attachmentmechanism 176 positioned within the slot 122 near its terminus thatcorresponds to a receiving mechanism 178 at an end of the infusioncartridge 112. The attachment and receiving mechanisms may be configuredto removably couple an interior volume of the cartridge with a volume ofthe pump that is sealed from the surrounding environment with thecoupling able to retain a fluid within the volumes even undersignificant pressure. The o-ring based tap attachment embodimentdiscussed below may be so configured and suitable for producing a leakfree detachable coupling that can withstand significant pressure. Thereceiving mechanism 178 may be configured to detachably couple with theattachment mechanism 176 such that the infusion cartridge 112. Theinfusion cartridge may be reversibly attached to the housing 124 of thepump device 114 for fluid delivery. In these embodiments, the attachmentmechanism 176 may include a pneumatic tap 179 having an O-ring 180 orother sealing device. The corresponding receiving mechanism 178positioned on an end of the infusion cartridge 112 may include a port182 through which the pneumatic tap 179 may be inserted.

The pneumatic tap 179 may include an inner channel 184 runningtherethrough. The channel 184 may allow the tap 179 to fluidly connectthe inner chamber volume 160 of the infusion cartridge 112 to the pumpdevice 114 once the tap 179 is inserted through the port. The innerchannel 184 of the tap 179 may connect to a pocket 186 of the pumpdevice 114 that may be filled with a fluid such as air. In someembodiments, the pocket 186 in the pump may hold approximately 1 mL ofthe air. When the fluid reservoir of the infusion cartridge may befilled with 3 mL insulin or other medicament a residual volume of theinner chamber may exist. This residual volume may be, for example, 1 mLof air. Upon connection between the infusion cartridge 112 and the pumpdevice 114, the residual volume of air within the inner chamber onvolume 160 and the air within the pocket 186 may equalize andequilibrate in both temperature and pressure. The volume of the pocket186 and volume 160 of the cartridge may also be in sealed relation withrespect to each other and with respect to the surrounding environment.Thus, the pressure within volume 160 will equalize with the pressure inthe pocket 186, thus, the pressure or pressure changes within volume 160may be measured by the pressure sensor 158 in the pocket 186.

The pump devices 114 and others described herein may include athermistor or other temperature sensor 188 including an optical orinfrared sensor that measures the temperature of the insulin or othermedicament within the reservoir 126 upon coupling the infusion cartridge112 with the pump device 114. Taking the temperature of the air may beimportant in measuring how much insulin or other medicament is in thefluid reservoir. In some embodiments, the sensor 188 can be integratedwith the attachment mechanism 176. For example, in the embodiment shownin FIGS. 7A-7B one or more of the pins of the attachment mechanism mayinclude a thermistor. In some embodiments shown in FIGS. 9A-14, thepocket 186 may have a thermistor or other temperature sensor 188positioned therein such that it can measure the temperature of the airin the pocket 186 as shown in FIG. 11. The pocket 186 may also include apressure sensor 158 coupled to the controller 168 for measuring pressurewithin the pocket 186 and volume 160 Because the air in the pocket 186is in fluid communication with the residual air within the chamber 160,the temperature and pressure of the air in the infusion cartridge 112surrounding the fluid reservoir 126 may be equal or approximately equalto the temperature and pressure of the air in contact with thetemperature sensor 188 and pressure sensor 158. In turn, the temperaturesensor 188 may provide a relatively accurate measurement of thetemperature of the insulin or other medicament within the reservoir 126.

In some cases, the infusion cartridge 112 and the pump device 114 may bereversibly attached to and detached from each other regardless of thestage of treatment of a particular infusion cartridge 112 or position ofthe drive mechanism 150. As best shown in FIGS. 12A-12B, the deliverymechanism 132 of the cartridge may be configured to couple to a portionof the drive mechanism 150 of the pump device 114. As described above,the drive mechanism 150 may include a rack and pinion system. The rackor drive shaft 190 may couple to the delivery mechanism 132 at one endand the pinion 192, shown in FIG. 14, at an opposite end. The portion ofthe rack 190 that couples to the delivery mechanism 132 may include aball or capturable feature 194 that inserts into a coupling element 196on the delivery mechanism 132. As the pinion 192 rotates it causeslinear motion of the rack 190 towards the delivery mechanism 132. Thecoupling element 196 of the delivery mechanism 132 may accept the ballfeature 194 from a lateral side as shown by the arrow 198 in FIG. 12B.The drive mechanism 150 inserts the ball feature 194 in this manner, forexample, upon insertion of a new infusion cartridge 112 into the pumpdevice 114. In this process, the rack 190 and ball feature 194 may be ina position that is rotated back away from the delivery mechanism 132.After coupling the infusion cartridge 112 within the slot 122, thepinion 192 rotates such that the rack 190 translates horizontally(laterally) towards the coupling element 196 of the delivery mechanism132 and the ball feature 194 inserts through a bore 200 of the couplingelement 196. A flange 202 surrounding at least a portion of the bore 200snaps in place around the ball feature 194 on the rack 190.

In some embodiments, the ball feature 194 of the rack 190 or drive shaftmay attach to the coupling element 196 in at least two generaldirections. The coupling element 196 may be snapped down over the ballfeature 194 of the rack 190 in a lateral direction as shown by the arrow198 in FIG. 12B as well as being engaged by the ball feature 194 of therack 190 in an axial direction or approach as shown by the arrow 204.The coupling element 196 including the bore or socket 200 of the spool156 in addition to having an axially oriented opening to bore 200 alsomay have a lateral opening to the bore 200. This dual-directionalinsertion capability may allow for the infusion cartridge 112 to beremoved and re-installed between pump devices 114, or any other suitablepump device embodiment such as pump devices 12 and 14, discussed herein,during a single infusion protocol and without unnecessary waste orinaccuracies. For example, when an infusion cartridge 112 is being usedfor the first time, the cartridge 112 may be inserted into the pumpdevice 114 by translating it in a vertical direction down through theslot 122. The rack 190 may be generally in a withdrawn configuration,axially displaced away from the spool 156 of the delivery mechanism 132.Once the cartridge 112 is filled and primed, the rack 190 may be woundor axially advanced by the pinion 192 such that it translates in anaxial direction and the ball feature 194 inserts through the axialopening into the bore 200 as shown by the arrow in FIG. 12B.

The ball or capturable feature 194 may be axially advanced until theflange of the coupling element 196 of the spool 156 snaps around theball feature 194. At any stage during the infusion protocol, theinfusion cartridge 112 may be removed from the pump device 114. Theinfusion cartridge 112 may be slid vertically upwards with respect tothe pump housing 124 of the infusion device 110 such that the ballfeature 194 exits the coupling element 196 of the spool 156 of thedelivery mechanism 132 through the lateral opening 198 of the socket200. The infusion cartridge 112 may then be re-inserted into anotherpump device by sliding it in a vertical direction downward through aslot of another housing until the ball feature 194 inserts through alateral opening of a coupling element of the other pump device. Thecartridge 112 may be advanced into the second pump device once againuntil the flange of the coupling element 196 snaps down from the toparound a ball feature on the rack of the drive mechanism 150 of thesecond pump device.

The delivery mechanism 132 of the infusion cartridge 112 may remain inposition providing a patient with the flexibility of changing pumpdevices during a single treatment protocol with a single infusioncartridge 112 regardless of the position of the drive mechanism 150. Themethod of switching between pump devices is described in more detailbelow. Although a ball-hitch type of configuration is shown in thefigures, the configuration of the attachment between the rack 190 andthe delivery or spool element 156 can vary. For example, the ball 194and socket 196 of the embodiment shown may be reversed with the socket196 on the drive shaft 190 and the ball element 194 on the spool ordelivery element 156 of the delivery mechanism 132. In addition, thecapturable element 194 of the detachable coupling may also include adifferent shape such as the oval capturable feature 206 shown in FIG.12C or the triangular capturable feature 208 shown in FIG. 12D.

In some cases, it may be desirable for the ball feature 194 and socket196 of the coupling element to be configured to snap or otherwisedetachably couple together such that there is little or no appreciableaxial play between the drive shaft 190 of the drive mechanism 150 andthe spool 156 of the delivery mechanism 132. Any of these embodiments orsimilar embodiments of capturable features 194 may be used anddetachably captured by a resilient socket or bore 200 in an axial orlateral direction as discussed above with regard to the spool embodiment156. In addition, the pump devices 114 between which the patient isswitching may be configured to communicate and prepare themselves toreceive an infusion cartridge 112 such that the drive mechanism 150translates to the appropriate position to maintain consistency ininfusion protocols as will be described in more detail below.

As discussed above, FIGS. 10 and 13 illustrate an embodiment of analignment mechanism 210 between the pump device 114 and the infusioncartridge 112. The pump device 114 may have a rail system that includesrails 212 positioned within the slot 122 that may be received withincorresponding grooves 214 in the infusion cartridge 112. In someembodiments, the rails 212 may be positioned about 90 degrees apartaround the receiving slot 122 that dove-tail or otherwise insert andcapture the grooves 124 on the outer housing or shell 130 of thecartridge 112 such that the cartridge 112 slidably couples to the pumpdevice 114 such as in a vertical plane or other plane. The rails 212 andgrooves 214 of the rail system may prevent lateral movement as thedelivery mechanism 132 couples with the drive mechanism 150.

For some embodiments, inadvertent lateral movement of the infusioncartridge 112 and, in turn, lateral movement of the delivery mechanism132 relative to the ball feature 194 may result in inadvertent deliveryof fluid to the patient 127 upon insertion of the cartridge 112. Therail system shown is configured to hold the head 216 of the infusioncartridge 112 in a proper and stable position once the deliverymechanism 132 inserts over the ball feature 194. The rails 212 of therail system for some embodiments may also have a tapered configurationas shown in cut away illustration of FIG. 13A. As shown, either or bothrails of the rail system 212 shown in FIG. 13 may have a transversedimension that flares to a larger dimension in a direction of engagementso as to provide a taper locking type arrangement between the rails 212and slots 214 of the rail system when fully engaged. The mating slots214 of the tapered rails 212 may have a matching tapered configuration.

For some embodiments, the taper or flare angle of the rails 212 andslots 214 may be about 0.5 degrees to about 3 degrees. The outer housing130 of the infusion cartridge 112 may also have three-dimensionalfeatures such as slots, knurling or any other suitable type of fingergrips 218 that may aid a user during the installation and removal of thecartridge from the pump device. Some embodiments may also include a slot(not shown) that bridges the structure of the cartridge 112 and pumphousing that is configured to allow a coin to be inserted into the slotand twisted to leverage the disengagement of the cartridge 112 from thepump housing. Typically, both halves of the slot would be aligned whenthe cartridge is fully engaged with the pump 114. In some cases, therail system or slot of the pump housing generally may be configured tocouple the cartridge to the pump with the top or head of the cartridgein a transversely fixed or secured arrangement to prevent any unwanteddisplacement between the delivery mechanism 132 and the drive mechanism150. The coupling between the cartridge 112 and pump 114 at theattachment mechanism end may be configured to allow for some transverseplay between the cartridge and the pump housing. The play between thecartridge and the pump may allow the attachment mechanism and receivingmechanism to be self-aligning.

A possible advantage of some system embodiments discussed herein may bethat the infusion cartridge 112 even after being inserted within areceiving slot 122 of a first pump device 114 can be removed andre-inserted into the receiving slot of a second pump device withoutresetting the second pump device. In some cases, the spool 156 of thedelivery mechanism 132 of the infusion cartridge 112 maintains its axialposition and air is not pulled into the pump chamber 220 or fluiddispensed during the change. Further, in some cases, the first andsecond pump devices 114 involved in the transfer for switch of thecartridge 112 from one pump 114 to another may be configured tocommunicate either directly or wirelessly with each other. Suchcommunication between pumps 114 or controllers 168 thereof may allow theposition of the drive mechanism 150 of the second pump to be set to theposition of the first pump 114 at the time the infusion cartridge 112was removed thus, providing seamless interchangeability during a singleinfusion protocol. In addition, after being inserted within a receivingslot of a given pump device, the infusion cartridge 112 can be removedand re-inserted into the same receiving slot of that pump device withoutresetting the pump device. In this way, system embodiments arecontemplated wherein the infusion cartridge 112 (a) is interchangeablebetween and/or among one or more different pump devices without thosepump devices having to be reset, and which pump devices may be identicalor different in any of their features, sizes, and functionalities, and(b) may be removed from and re-inserted into a receiving slot on asingle given pump device without resetting the given pump. Such atransfer with communication between pumps 114, and other pumpembodiments, allows the transfer to be made without changing the axialposition of the spool 156 of the delivery mechanism 132 relative to thevarious ports of the delivery mechanism 132. For some embodiments, thesocket or bore 200 of the coupling element 196 of the spool 156 may beconfigured to be self-centering such that the ball or capturable element194 of the drive shaft 190 will be engaged and snapped into place evenif the axial alignment of the ball element 194 and socket 196 are notperfectly aligned at the time of insertion or engagement.

In some cases, a new infusion cartridge 112 may be removed from itssterile packaging and inserted into the receiving slot of a first pumpdevice 114. The attachment mechanism 176 of the first pump device 114may couple with the receiving mechanism 178 of the infusion cartridge112. The drive mechanism 150 at this stage may remain physicallyunconnected to the delivery mechanism 132. Once the cartridge 112 issecured to the pump 114, a patient 127 can fill the infusion cartridge112 with insulin or other suitable medicament using a syringe having ahypodermic needle 222 inserted through a septum 136 of the fill port 134(see, for example, FIG. 14). The pressure inside a vented volume 160 ofthe infusion cartridge 112 increases and is directly related to how muchfluid was added to the fluid reservoir 126. For one example, if 3 ml offluid is added to a fluid reservoir embodiment 126, the pressure insidethe vented volume 160 of the infusion cartridge 112 may increase fromabout 0 psi to approximately 22 psi, depending on the volume of thevented volume 160. The septum 136 is configured to conform around theneedle 222 and provide a resilient seal around an outer surface of theneedle 222. The septum may have a thickness of about 0.05 inches toabout 0.15 inches, more specifically, about 0.08 inches to about 0.1inches, and may be made from an elastic resilient material such assilicone rubber having a shore hardness of about 45 A to about 55 A.

The pressure increase of 22 psi may then be used by the controller todetermine the amount of insulin or other medicament or fluid that hasbeen put into the reservoir 126. Pressure change measurements may alsobe used to measure an amount or amounts of fluid dispensed from thereservoir 126. Other means of measuring fluid volumes or changes offluid volumes may also be useful in some embodiments. In some cases,methods and devices for determination of a fluid volume as used in anysuitable application discussed herein may include acoustic sensors,including a loud speaker and one or more microphones which may be usedfor acoustic volume determination, optical devices, capacitivemeasurement devices, deflection measurement methods, thermal time offlight methods or any other suitable methods. The change in pressure inthe system may be used to determine the volume of fluid added ordispensed from the reservoir by means of a ideal gas law calculation. Ifthe volume of the system is known, i.e., the volume of the pocket 186and volume of the shell 130 are known, then the ideal gas law equationPV=nRT where P is pressure, V is volume, T is temperature and n and Rare constants, may be used to calculate changes in volume based onchanges in pressure assuming the temperature is also known. Thetemperature of the gas within the cartridge may be measured by atemperature sensor within the pocket 186 such that when fluid is addedor dispensed from the reservoir, the pressure sensor will measure achange in pressure. The change in pressure is then used to calculate thechange in volume that caused the pressure change. This method of volumemeasurement, as well as the other methods discussed above, may be used aredundancy check on electrical volume measurements, error detectionwithin the pump system 110 or components thereof, or any other suitablepurpose. The use of the ideal gas law for volume measurement may also beuseful for dispensing fluids, including medicaments such as insulin orany other suitable medicament or material, without directly contactingthe fluid.

The pressure inside the infusion cartridge 112, and particularly thevented volume 160 of the infusion cartridge 112, may be measured by apressure sensor 158 disposed in the infusion cartridge 112 or in thepump device 114 in a volume, such as pocket 186. Pocket 186 is aninterior volume disposed within the pump device 114 and in fluidcommunication with an interior volume of the fluid cartridge 112. Thepocket 186 is in sealed relation with the interior volume 160 of thecartridge. As such, a pressure sensor 158 disposed within the volume ofthe pocket 186 will read the pressure of the volume 160 in thecartridge, but can remain with the pump device 114 after disposal of thedisposable cartridge 112. This configuration lowers the cost of thecartridge while providing the means of pressure measurement within thecartridge 112. In some embodiments, data from the pressure sensor 158may be used to provide a measurement of how much insulin or othermedicament is being delivered by the first pump device 114.

Once the infusion cartridge 112 is filled, the drive mechanism 150 ofthe first pump device 114 may then connect to the delivery element orspool 156 of the infusion cartridge 112. For example as in FIGS.12A-12B, the pinion 192 (not shown) can drive the rack or drive shaft190 in an axial direction until the ball feature 194 applies an axialforce against the coupling element 196 and moves the spool 156 in adistal direction until reaching a hard stop 226. The drive shaft 190 maythen be advanced further distally in an axial direction until the ballelement 194 enters the axial socket or coupling element 196 of the spool156 and snaps into the bore 200 of the delivery element or spool 156.The controller 168 of the first pump device 114 may then transmitinstructions to the motor 152 of the delivery mechanism 132 which may beconfigured to perform a priming protocol.

The priming protocol may be used to prepare the infusion cartridge 112and the first pump device 114 for delivery of a desired fluid to apatient 127. The patient 127 can input externally supplied values intothe data input interface 228 of the first pump device 114. The datainput interface 228 may receive the user input data and communicate thatdata to the processor 170 of the controller 168. For some embodiments,the controller 168 may be programmed or otherwise configured to generatean estimate of an amount of the insulin or other medicament to bedelivered to the patient 127 as either a baseline, bolus or any othersuitable type of fluid delivery regimen. The controller 168 may thencommunicate the estimate to the display 230 for patient evaluation. Thefirst pump device 114 may then deliver an approved quantity ofmedicament to the patient 127 according to the selected protocol. Theuser input data may include one or more of a blood glucose level, astress level, a physiological condition, a complexity of a meal to beingested, an activity level, user history, and the like.

At any stage during an infusion protocol, the patient 127 may slide theinfusion cartridge 112 vertically through the slot 122 up away from theattachment mechanism 176 of the first pump device 114. In some cases itmay be desirable for the patient 127 to enter data into the interface ofthe first pump 114 which is indicative that the cartridge 112 is goingto be removed from the pump 114. As discussed above, the controller 168of the first pump 114 may use this data to configure the position of thespool 156 of the delivery mechanism 132 of the first pump 114 orcommunicate information regarding the position of the spool 156 of thefirst pump 114 to the controller 168 of the second pump. In this way,the controller 168 of the second pump may use this information toconfigure the drive shaft 190 of the drive mechanism 150 to facilitateengagement of the cartridge 112 with the second pump. The controller 168may also be configured to halt an ongoing delivery protocol includingany axial advancement or cycling of the delivery element 156 at thistime to avoid removal of cartridge 112 during delivery of fluid to thepatient 127.

During removal of the cartridge 112 from the first pump 114, the ballfeature 194 on the rack or drive shaft 190 may snap through the lateralopening 198 in the coupling element 196 until the delivery mechanism 132of the cartridge 112 is free of the drive mechanism 150 of the firstpump 114. The removal of the infusion cartridge 112 from the first pumpdevice 114 may require a certain degree of force imparted by the patient127 such that inadvertent removal or uncoupling of the infusioncartridge 112 from the pump device 114 is avoided. The finger grips 218or other three-dimensional feature on the outer housing 130 of theinfusion cartridge 112 may aid a patient 127 in the removal of acartridge 112 from the pump device 114. As discussed above, once theattachment and receiving mechanisms 176 and 178 are uncoupled, the firstpump device 114 may send a signal to the second pump device such thatthe second pump device may configure itself in preparation for receivingthe infusion cartridge 112. Such a signal may be a radiofrequencysignal, for example. In some embodiments, the drive shaft 190 of thedrive mechanism 150 of the second pump device may be adjusted in anaxial direction in accordance with the data sent by the first pump 114.

In some cases, the axial position of the drive shaft 190 of the secondpump may be adjusted to the proper position such that when the infusioncartridge 112 is inserted into the slot of the second pump device theball feature 194 of the rack 190 may be directly inserted through thelateral opening 198 on the coupling element 196 without causing axialdisplacement of the coupling element 196. The coupling element 196 thensnaps over the ball 194 in a top-down direction. In some embodiments,rather than adjusting the rack 190 to match an axial position of therack 190 of the first pump, the rack 190 of the second pump may insteadbe fully proximally retracted upon the initiation of a transfer process.In such a process, the infusion cartridge 112 may be inserted into theslot 122 of the second pump without any mechanical engagement betweenthe coupling element 196 of the delivery mechanism 132 or the ball 194of the drive mechanism 150.

Once the cartridge 112 is engaged with the pump 114, the controller 168may then instruct the drive shaft or rack 190 of the drive mechanism 150to advance in a distal direction until pushing the spool 156 of thedelivery mechanism 132 to a hard stop 226 within the bore 220. Once thespool 156 is upon the hard stop 226, further axial advancement of thedrive shaft 190 in a distal direction will force the ball feature 194 ofthe drive shaft 190 into the socket 196 of the spool or delivery element156 until it snaps into place and is mechanically captured by the socket196. If a glucose meter 20 is being stored within the slot 122 of thesecond pump device, it may be removed prior to inserting the infusioncartridge 112 into the slot 122 and replaced into the slot 122 of thefirst pump device 114.

The patient's infusion set 125 may remain connected to the infusioncartridge 112 via the set connector 232 during transfer between thefirst and second pump devices. The sterility of the infusion cartridge112 and the infusion set 125 is maintained regardless of how many timesthe infusion cartridge 112 is removed and re-inserted into a pump device114. Neither the drive mechanism 150 nor the attachment mechanism 132 ofthe pump devices 114 breaks the sterile field of the fluid reservoir126. Similarly, connection between the pneumatic tap 179 and the port182 of the receiving element does not break the sterile field of thefluid reservoir 126. The insulin or other medicament is contained withinthe fluid reservoir 126 which may be a closed sterile environment thatis not broken or exposed during repeated installations between the firstand second pump devices 114.

Referring to FIGS. 14-17, the embodiment of the delivery mechanism 132shown in FIG. 12A is shown in a fluid delivery cycle sequence whereinfluid from the interior volume of the reservoir 126 is drawn into thebore 220 of the delivery mechanism 132 and dispensed from the dispenseoutlet port 142. The dispense cycle embodiment shown in FIGS. 14-17illustrates a dispense cycle without a venting of the vented volume 160of the infusion cartridge 112 of the pump system 110. FIG. 18 shows anoptional venting step wherein a vent second volume 234 of the deliverymechanism 132 is disposed in communication with a vent inlet port 146and a vent outlet port 148 of the delivery mechanism 132. The dispenseand vent method embodiments discussed herein may also be combined withone or more methods and devices for measuring and/or confirming a volumeof fluid dispensed or flow from a delivery mechanism 132. Venting of thevolume of the shell 130 surrounding the reservoir may be useful in orderto prevent pressure build up of the fluid in the reservoir 126 whichmight then force fluid 121 past seals of the system to a patient 127.

Such devices and methods for measuring and/or confirming a volume ofmaterial dispensed and the like from a delivery mechanism 132 or flowmetering device are discussed in co-pending, commonly owned U.S. patentapplication Ser. No. 12/714,299, filed Feb. 26, 2010, by M. Rosinko etal., titled Methods and Devices for Determination of Flow ReservoirVolume, which is incorporate by reference herein in its entirety. Themethods and devices discussed therein include measuring a pressureincrease in a vented volume of a fluid reservoir cartridge between therigid shell and flexible membrane of the fluid reservoir as discussedherein. Such pressure measurements may be used to determine or confirman amount of fluid dispensed, as well as detect malfunctions in thecomponents of a delivery mechanism 132 or drive mechanism 150 of a pumpsystem 110.

Other methods and devices used for calculating and measuring flowvolumes dispensed are discussed in U.S. patent and patent applicationNos. 7,008,403, filed on Jul. 19, 2002, by Scott Mallett, titledInfusion Pump and Method for Use, 7,341,581, filed on Jan. 27, 2006, byScott Mallet, titled Infusion Pump and Method for Use, 7,374,556, filedon Jan. 31, 2006, by Scott Mallett, titled Infusion Pump and Method forUse, 2007/0264130, filed on May 4, 2007, by Scott Mallett, titledInfusion Pumps and Method for Use, and 2009/0191067, filed on Jan. 25,2008, by Paul DiPerna, titled Two Chamber Pumps and Related Methods,which are all incorporated by reference herein in their entirety. Someembodiments discussed in these references include the use of the idealgas law or Boyle's law, for determination of a volume of materialdispensed from a device 110 or reservoir 126 thereof. Such methods anddevices may be used in conjunction with or as part of suitableembodiments 10 or 110 discussed herein.

Referring again to FIG. 14, a portion of the fluid reservoir cartridge112 including a delivery mechanism 132 illustrated in FIG. 12A is shownin section as well as a portion of a drive mechanism 150 of an infusionpump. The disposable fluid cartridge 112 includes the delivery mechanism132 which has a delivery mechanism body 236 and a bore 220 disposed inthe delivery mechanism body 236. The bore 220, which may have asubstantially round transverse cross section as shown in FIG. 14A,includes a distal end 238, a proximal end 240 disposed towards the drivemechanism 150 of the infusion pump 114, an interior volume 242, areservoir inlet port 138, a fluid dispense port 142, a vent inlet port146 and a vent outlet port 148. The spool 156, which may also have asubstantially round transverse cross section, is slidingly disposedwithin the bore 220 and forms a collapsible first volume 244 and a ventsecond volume 246 with the bore 220.

The collapsible first volume 244 of the delivery mechanism 132 may bepositionable to overlap the reservoir inlet port 138 independent of anoverlap of the fluid dispense port 142. The collapsible first volume 244may be formed between a first seal 248 around the spool 156, a secondseal 250 around the spool, an outer surface of the spool body betweenthe first and second seal 250 and an interior surface 252 of the bore220 between the first and second seal 248 and 250. The first and secondseals 248 and 250 are axially moveable relative to each other so as toincrease a volume of the collapsible volume 244 when the first andsecond seals 248 and 250 are moved away from each other and decrease thecollapsible volume 244 when the seals 248 and 250 are moved closertogether.

The second seal 250 is disposed on a main section 254 of the spool 156of the delivery mechanism 132 and moves in conjunction with movement ofthe rest of the spool. A proximal end 256 of the spool 156 is coupled toa ball portion 194 of a drive shaft 190 of the drive mechanism 150 ofthe pump device 114. The drive mechanism 150 includes a rack and pinionmechanism actuated by an electric motor 152 through a gear box 154. Assuch, the second seal 250 moves or translates axially in step with axialtranslation of the spool 156 and drive shaft 190. The first seal 248,however, is disposed on a distal section 258 of the spool 156 which isaxially displaceable with respect to the main section 254 of the spool156. The distal section of the spool 156 is coupled to the main sectionof the spool by an axial extension 260 that is mechanically captured bya cavity 261 in the main section 254 of the spool 156. Thisconfiguration allows a predetermined amount of relative free axialmovement between the distal section 258 of the spool and the nominalmain section 254 of the spool 156.

For some embodiments, a volume of a “bucket” of fluid dispensed by acomplete and full dispense cycle of the spool 156 may be approximatelyequal to the cross section area of the bore 220 multiplied by the lengthof displacement of the captured axial extension of the spool 156 for thedistal section 258. The complete bucket of fluid may also be dispensedin smaller sub-volumes in increments as small as a resolution of thedrive mechanism 150 allows. For some embodiments, a dispense volume orbucket defined by the complete collapsible volume 244 of the deliverymechanism 132 may be divided into about 10 to about 100 sub-volumes tobe delivered or dispensed. In some cases, the maximum axial displacementbetween the distal section and main section of the spool may be about0.01 inch to about 0.04 inch, more specifically, about 0.018 inch, toabout 0.022 inch.

For some embodiments, the bore 220 of the delivery mechanism may have atransverse dimension or diameter of about 0.04 inches to about 0.5inches, more specifically, about 0.08 inches to about 0.15 inches. Forsome embodiments, the spool 156 may have a length of about 10 mm toabout 40 mm, more specifically, about 15 mm to about 20 mm. The spool156 and housing of the delivery mechanism 132 may be made from anysuitable material or materials including polymers or plastics such aspolycarbonate, PEEK, thermoplastics, cyclic olefin copolymer, and thelike. In some cases, the seals disposed on the spool may have an outertransverse dimension or diameter that is slightly larger than that ofthe spool 156. In some instances, the seals on the spool may have anaxial thickness of about 0.01 inches to about 0.03 inches and may bemade from materials such as butyl, silicone, polyurethanes or the likehaving a shore hardness of about 65 A to about 75 A, more specifically,about 70 A.

In some instances, a vent second volume 246 of the delivery mechanism132 may be formed by the spool 156 and bore 220 of the deliverymechanism 132. For some embodiments, the vent second volume 246 may beformed by a third seal 262 disposed around the spool 156 and a fourthseal 264 also disposed around the spool and axially separated from thethird seal 264. The axial separation between the third and fourth seals262 and 264 forming the vent second volume 246 may be greater than theaxial separation between the vent inlet port 146 and vent outlet port148 of the bore 220 in some instances. The vent second volume 246 isalso formed by an outside surface 266 of the spool 156 between the thirdand fourth seal 262 and 264 and an inside surface 252 of the bore 220between the third and fourth seal 262 and 264.

The vent second volume 246 may be axially displaceable with the movementof the spool 156 and may also be positionable by such axial displacementin order to simultaneously overlap the vent second volume 246 with thevent inlet port 146 and vent outlet port 148 of the bore 220. Such anoverlap of both the vent inlet port 146 and vent outlet port 148 putsthese ports in fluid communication with each other and allows anequilibration of pressure between the vented volume 160 of the reservoircartridge 112 and the environment surrounding the vent outlet port 148.In most cases, the vent outlet port 148 will be in communication withthe atmosphere and air will pass from the environment surrounding thevent outlet port 148, through the vent second volume 246 of the bore 220and into the vent volume 160 to replace the fluid dispensed subsequentto the last vent cycle. When the vent inlet port 146 and vent outletport 148 do not share a common volume formed by the spool and bore ofthe delivery mechanism 132, they are typically isolated and no ventingof the vented volume takes place.

A collapsible fluid reservoir 126 of the infusion cartridge 112 shown inFIG. 14 may be bounded by or disposed within a flexible membrane orlayer 128. The fluid reservoir 126 may include an interior volume 140 influid communication with the reservoir inlet port 138 of the bore 220 ofthe delivery mechanism 132. A top portion of the flexible membrane orlayer 128 may be clamped or otherwise sealed to an extension or boss 268of the reservoir inlet port 138 that extends into the cartridge 112. Inthis configuration, the interior volume 140 of the collapsible fluidreservoir 126 may be isolated or sealed from the surrounding environmentexcept for the reservoir inlet port 138 which is in fluid communicationwith the bore 220 of the delivery mechanism 132. A substantially rigidshell 130 may be disposed about the collapsible fluid reservoir with aninterior volume that contains the collapsible fluid reservoir. Thevented volume 160 of the cartridge 112 is disposed between an outersurface 162 of the flexible membrane 128 and an interior surface 164 ofthe rigid shell 130. The vent inlet port 146 is in fluid communicationwith the vented volume 160 and the bore 220 of the delivery mechanism132. The vent inlet port 146 is disposed proximally of the reservoirinlet port 138 for the embodiment of the delivery mechanism 132 shown.

In operation, the spool 156 and the particular volumes formed betweenthe spool 156, the bore 220 and the circumferential seals 248, 250, 262and 264 disposed on the spool of the delivery mechanism 132 aretypically translated in a proximal and distal direction in order to movethe volumes into and out of communication with the various ports of thebore 220. This axial movement in alternating proximal and distaldirections of the spool 156 within the bore 220 may be used to put thevarious ports in fluid communication with translatable volumes of thedelivery mechanism 132 and other ports of the mechanism. For reliableoperation, it may be desirable in some circumstances for the spool 156and the circumferential seals 248, 250, 262 and 264 disposed about thespool 156 to move smoothly within the bore 220 of the delivery mechanism132 while maintaining a seal between an outside surface 266 of the spool156 and an inside surface 252 of the bore. It may also be desirable forthe seals 248, 250, 262 and 264 disposed on the spool 156 to moveaxially back and forth within the bore 220 while maintaining a seal andwith a minimum of friction. Achieving these features of the spool 156may be facilitated with the use of particular seal configurations orgland configurations used to house the seals of the spool embodiments.

Referring to FIG. 14C, a specialized seal gland 270 is shown that may beused to form a dynamic seal between the spool 156 and bore 220 of thedelivery mechanism 132 using an o-ring type seal. The gland may beuseful for achieving positive displacement in an infusion pump deliverymechanism 132. Such a gland configuration may be particularly useful inachieving a reliable seal while accommodating various manufacturingtolerances of a bore 220, a spool 156 and seals 248, 250, 262 and 264such as o-ring type seals, quad ring type seals or any other suitabletype of seal that may be used in a circumferential groove of a spool 156or the like. The configuration shown may also be useful for minimizingthe effects of static friction and seal compliance on dispense volumeerror by minimizing seal width and minimizing variability due to themanufacturing tolerances of the components of the delivery mechanism132. The configuration may achieves some or all of these benefits byutilizing a gland 270 that includes a seal contact surface that mayinclude angled edges and an overflow channel.

The angled surfaces or edges may be configured to compress an o-ringsemi-axially and rely on the elastic memory of the seal or o-ringmaterial to create a dynamic seal. The angled surfaces or any othersuitable configuration may provide both axial stability of the seal aswell as outward radial support of the seal to provide positive andsealing contact with an inside surface of the bore or any otherappropriate sealing surface. The mixed radial and axial support providedby the angles edges or surfaces may also be useful for allowingsubstantially equal distribution of tension of the seal around the glandwhich may also provide a centering function of the body of the seal withrespect to a longitudinal axis of the spool or other sealed element. Theo-ring or seal may be sealed around at least one of the angled edges orsurfaces and an inside surface of the bore 220 to prevent an axial flowof fluid past the seal. The overflow channel provides a volume of thegland adjacent the seal that accommodates a flow of excess seal materialwhen the seal is compressed between two elements. A typical groovedgland used for o-ring type seals may force a flow or overflow of sealmaterial into the gap between the two sealed elements resulting inexcessive or inconsistent friction or stiction between the elements. Theoverflow channel provides a volume for the excess seal material to flowinto instead of a gap between sealed surfaces. The gland embodimentshown in FIG. 14C may be used for any suitable seal embodiment discussedherein including seals 248, 250, 262 and 264. The gland may be usefulfor providing a reliable seal between the spool 156 and bore 220 withconsistent frictional resistance between these elements whileaccommodating a significant variation or tolerance in the sizes of thecomponents. The configuration of the gland 270 may also aid in theassembly of the o-ring type seal with the spool 156 as the angledsurfaces or edges of the gland 270 tend to have a centering influence onthe seal being inserted into the gland 270. A seal disposed in a glandsuch as gland 270 also tends to have a good axial stability withoutflowing into the gap between sealed surfaces. For infusion pumps such aspump system 110, the stable axial position of the seal with respect tothe spool provides for more accurate metering of fluid being dispensedas well as more consistent friction or resistance between the spool 156and bore 220.

FIG. 14C shows an o-ring seal including a gland 270 for seating ano-ring 272. The gland 270 has an outer circumferential groove 274extending circumferentially around a longitudinal axis of a cylindricalbody of the spool 156 of the delivery mechanism 132. The circumferentialgroove 274 may include an angled first edge 276 or surface and an angledsecond edge 278 or surface opposite the angled first edge 276. An inneroverflow channel 280 may be disposed below the angled channel 274 formedby the angled first and second edges or surfaces 276 and 278. An o-ringembodiment 272 is disposed in the gland 270 with a first circumferentialband 282 of the o-ring 272 resting on the first angled edge 276 and asecond circumferential band 284 of the o-ring 272 resting on the secondangled edge 278 of the angled channel 274 of the gland. The o-ring 272is also shown in FIG. 14C resting above the overflow channel 280 withthe o-ring 272 in a substantially uncompressed state. For the embodimentshown, the overflow channel 280 provides a circumferential volume in thegland 270 for the material of the o-ring 272 to flow into rather thanexert excessive force against an inside surface of the bore 220 if theo-ring 272 has a particularly large section for the application, thebore 220 is at a small end of the tolerance specification or the like.The overflow channel 280 and angled channel 274 configuration of thegland 270 are configured to accommodate tolerance variations in thecomponents of the spool 156, bore 220 and seals 248, 250, 262 and 264 ofthe delivery mechanism 132.

For some gland embodiments 270, the angled first and second edges 276and 278 may form a total inclusive angle with each other of about 20degrees to about 60 degrees, as indicated by the arrow 286 in FIG. 14C.For the embodiment shown, an outer surface 288 of the o-ring 272 restsabove a nominal outer surface 266 of the cylindrical body of the spool156 and does not extend substantially into the overflow channel 280 whenthe o-ring 272 is in an uncompressed state. However, a center 290 of theseal element cross section of the o-ring 272 is disposed below thenominal outer surface 266 of the cylindrical body of the spool 156 whenthe o-ring 272 is in a substantially uncompressed state. For theembodiment shown, the overflow channel 280 of the gland 270 has asubstantially straight-walled configuration. The gland embodiment 292shown in FIG. 14D includes an outer circumferential groove 294 having aradius 296 on a first edge 298 and a radius 300 on a second edge 302. Anoverflow channel 304 is disposed below the first radiused edge 298 andsecond radiused edge 302. The overflow channel 304 shown in FIG. 14Dalso has a substantially straight-walled configuration. The glandembodiments of 220 and 292 FIGS. 14C and 14D each have first and secondedges that provide a combination of axial and radial support to theouter surface 288 of the o-ring 272 disposed in the gland 270 or 292.The o-ring is disposed in these gland embodiments 270 and 292 with anouter surface 288 of the o-ring 272 disposed above the nominal surface266 of the spool 156 or other sealed structure within with the gland isbeing utilized. For some such gland embodiments 270 or 292, thevolumetric percent gland fill may be about 70 percent to about 90percent where the volumetric percent gland fill is the volume of ano-ring 272 to be used in a particular gland 270 or 292 divided by thevolume of the gland 270 or 292 as a whole.

Some gland embodiments, such as the gland 306 shown in FIG. 14E, utilizeonly axial compression or support of the o-ring disposed in the gland306 and would essentially have a total angle of the groove of up toabout 5 degrees, more specifically, about 0 degrees to about 3 degrees.Such a gland 306 may be configured as a straight-walled groove 308 thatmay be sized to have a volumetric percent gland fill similar to that ofthe embodiments of FIGS. 14C and 14D discussed above. Such a glandembodiment 306 may also be configured to provide a predetermined amountof axial compression on the o-ring 272. For some such embodiments, thepercent compression of the o-ring 272/gland seal 306 may be about 60percent to about 85 percent where the percent compression is determinedby the width of the groove 308 of the gland 306 divided by the thicknessof the o-ring 272 of the seal. For any of the gland embodimentsdiscussed above, there is a predetermined percentage of axial support orcompression of the o-ring 272 and a useable overflow channel componentof the gland.

In use, referring again to FIG. 14, once the reservoir cartridge 112 ofthe infusion pump system 110 has been installed or otherwise snappedinto place in the slot 122 of the pump device 114, the interior volume140 of the collapsible reservoir 126 may then be filled with a desiredfluid 121 for dispensing. In order to fill the reservoir 126, the spool156 may be translated by the drive mechanism 150 to a hard stop position226 as shown in FIG. 14. In the hard stop position 226 the first seal248 is disposed proximally of a relief port 310, the relief port 310being disposed in fluid communication between a distal end 238 of thebore 220 and the reservoir volume 140. In the hard stop position, thefirst seal 248 is also disposed distally of the reservoir inlet port138. In the hard stop position, a distal end 316 of the spool 156 iscontacting a distal end 238 or shoulder portion 312 of the distal end238 of the bore 220 to prevent any further distal displacement of thespool 156.

A reservoir fill port 134 is disposed on a top portion of the bore 220substantially opposite the bore 220 of the reservoir inlet port 138.With the spool 156 and seals 248, 250, 262 and 264 thereof sopositioned, a patient may then obtain an amount of a desired fluid to bedispensed. In some cases, if the desired fluid to be dispensed isinsulin or other suitable medicament, the patient 127 typically storesthe insulin in a refrigerated glass container. The insulin is thenaccessed with a hypodermic needle 222 of a syringe device and drawn intoan interior volume of the syringe (not shown). The tip of the hypodermicneedle 222 of the syringe may then be pushed through a septum membrane136 that seals the reservoir fill port 134 as shown and fluid manuallydispensed from the interior volume of the syringe, through thehypodermic needle 222, through a bubble trap volume 314 in the bore 220of the delivery mechanism 132 and into the interior volume 140 of thecollapsible reservoir 126 of the cartridge 112 as shown by the arrow 318in FIG. 14.

As discussed above with regard to other embodiments of the deliverymechanism 132, the vented volume 160 of the cartridge 112 disposedbetween an outside surface 162 of the flexible membrane 128 of thecollapsible reservoir 126 and an inside surface 164 of the rigid shell130 may include or be in operative communication with a pressure sensor158 (not shown). The pressure sensor 158 may be used to monitor thepressure within the vented volume 160 during the filling of thecollapsible reservoir 126. The controller 168 of the pump system 114 maybe programmed with information regarding the fixed volume of the rigidshell 130 of the cartridge 112 and configured to calculate the volume offluid loaded into the collapsible reservoir 126 based on the pressurerise within the rigid shell 130 upon filling of the collapsiblereservoir 126. The data regarding the volume of fluid loaded into thecollapsible reservoir 126 may be stored and used to calculate anddisplay data later in the use cycle such as fluid remaining in thecollapsible reservoir 126 and the like.

Once the collapsible reservoir 126 contains a desired amount of a fluid121 to be dispensed, a dispense cycle may be initiated by driving thespool 156 with the drive mechanism 150 based on commands from acontroller 168 of the pump device to a position with the collapsiblefirst volume 244 in communication with the reservoir inlet port 138. Thehad stop position shown in FIG. 14 is such a position. If the spool 156has been driven to this hard stop position 226 in a distal directionfrom previous proximal position, the friction generated between thefirst seal 248 of the spool 156 and the inside surface 252 of the bore220 will have collapsed the collapsible volume 244 of the deliverymechanism 132 with the first seal 248 and second seal 250 in a leastaxially separated state. In this state, the collapsible volume 244 has aminimum volume. Such a state of the delivery mechanism 132 is shown inFIG. 14. Once in this pre-fill position, the spool 156 may then bedriven so as to axially separate the first and second seals 248 and 250(and the main section 254 of the spool 156 and distal section 258 of thespool 156) of the collapsible first volume 244 and draw fluid into thefirst volume 244 through the reservoir inlet port 138 from the reservoir126 as shown by the arrow 320 in FIG. 15. As the fluid 121 is drawn intothe collapsible volume 244, the pressure within the vented volume 160decreases. As previously discussed, this drop in pressure may be used inaccordance with the ideal gas law to determine the amount of materialtaken from the collapsible reservoir 126. An unexpected reading based onthe magnitude of the translation of the main section 254 of the spool156 may also be used to detect a failure of a portion of the deliverymechanism 132 in some cases.

The collapsible volume 244 of the delivery mechanism 132 may becompletely filled by proximally retracting the main section 254 andsecond seal 250 of the spool 156 relative to the first seal 248 anddistal section 258 of the spool 156 as shown by arrow 322 on spool 156in FIG. 15A. Once filled, the spool 156 may then be driven in a proximaldirection as shown in FIG. 15B wherein there are two seals 248 and 250disposed in the bore 220 between the reservoir inlet port 138 and reliefport 310 and the dispense port 142. As shown by arrow 22 and arrow 324in FIG. 15B, both the main section 254 and distal section 258 of thespool 156 are proximally retracted together. The captured axialextension of the distal section 258 by the main section 254 pulls thedistal section along without axial displacement between the main section254 and distal section 258 of the spool 156. The dispense port may be influid communication with a subcutaneous portion of a patient's body 127as shown in FIGS. 9D and 9E. The delivery mechanism 132 configurationillustrated in FIGS. 14-18 always includes at least one seal 248 or 250disposed in the bore 220 between the reservoir volume 140 and material121 disposed therein and the dispense port 142 in order to prevent afree flow condition wherein the material 121 in the reservoir 126 is inuninterrupted communication with the patient's body 127.

Once filled, the spool 156 and filled collapsible volume 244 may beproximally displaced with the drive mechanism 150 to a position with thecollapsible first volume 244 in communication with the fluid dispenseport 142 of the bore 220 as shown in FIG. 16. In the configuration shownin FIG. 16, the collapsible first volume 244 of the delivery mechanism132 is in fluid communication with the fluid dispense port 142, but thevent second volume 246 is only in fluid communication with the ventinlet port 146 and not the vent outlet port 148. Thus, in the positionshown, the spool 156 of the delivery mechanism 132 is configured todispense the fluid 121 in the collapsible volume 244 without venting ofthe vented volume 160 of the cartridge 112. This arrangement allows oneor more dispense cycles to be carried out independent of venting of thevented volume 160.

Once the spool 156 is positioned as shown in FIG. 16, the main sectionof the spool 156 may then be axially driven in a distal direction by thedrive mechanism 150 with the distal section 258 of the spool remainingstationary or substantially stationary. This axial distal movement ofthe main section 254 as indicated by arrow 326 on the spool 156 shown inFIG. 17, serves to at least partially collapse the collapsible firstvolume 244. Collapsing the first volume 244 of the delivery mechanism132 dispenses fluid from the collapsible first volume 244 through thefluid dispense port 142 as shown by the arrow 328 in FIG. 17. For someembodiments, the axial distance of the translation between the firstseal 248 and second seal 250 may be about 0.015 inches to about 0.025inches. In some instances, the bore 220 may have an inner transversedimension or diameter of about 0.10 inches to about 0.20 inches.

After filling of the collapsible volume 244 of the delivery mechanism132 as shown in FIG. 16, if venting of the vented volume 160 is desired,the spool 156 may be driven by the drive mechanism 150 to a positionwith the vent second volume 234 in simultaneous communication with theinlet vent port 146 and vent outlet port 148 as shown in FIG. 18. Thisarrangement allows the vented volume 160 of the reservoir cartridge 112to vent as shown by the arrow 330 in FIG. 18. In such circumstances, thevent second volume 234 arrives at the same pressure as the vent outletport 148 and vented volume 160. In some instances, the vent outlet port148 may be at ambient atmospheric pressure and the vented volume 160 isbrought to ambient atmospheric pressure during every venting cycle.

In some cases, the vented volume 160 of the cartridge is vented aboutevery 2 dispense cycles to a bout every 10 dispense cycles. In somecases, the vented volume 160 may be vented about every 3 dispense cyclesto a bout every 7 dispense cycles. However, any desired interval ofventing cycles to dispense cycles may be used. For some embodiments, theventing of the vented volume 160 of the infusion cartridge 112 may betriggered by the detection or measurement of a pressure differencethreshold in the vented volume 160. That is, if the pressure measured inthe vented volume 160 of the infusion cartridge 112 is above or below apredetermined valued relative to the ambient pressure, the controller168 will initiate a venting cycle to vent the vented volume 160 andequalize the pressure in the vented volume 160. For some embodiments,the magnitude of such a threshold pressure difference may be up to about1 psi gauge, more specifically, up to about 0.1 psi gauge.

FIGS. 19A-19E illustrate an embodiment of a spool 340 of a deliverymechanism 342 that includes a sliding seal configuration for thecollapsible first volume 344 of the delivery mechanism 342. The deliverymechanism 342 may have some or all of the same features, dimensions,materials and methods of use as those of any other delivery mechanismdiscussed herein, and particularly delivery mechanism 132. In addition,it should be noted that some or all of the suitable features,dimensions, materials and methods of use of the delivery mechanism 342may be used or incorporated into any other infusion system, orcomponents thereof, discussed herein.

In some cases, the collapsible first volume 344 of the deliverymechanism 342 includes a volume bounded by at least one distal seal 346that is axially displaceable relative to a slide section of the spoolbody 348 and which may form a substantially fluid tight seal between anoutside surface 350 of the seal 346 and an inside surface 252 of thebore 220. A fluid tight seal may also be formed between an outsidesurface 352 of a slide portion 354 of the spool 340 and an insidesurface or inside diameter 356 of the seal. More specifically, thedelivery mechanism 342 of an infusion pump system 358 may include thebore 220 disposed in the delivery mechanism 132 body and the spool 340disposed in the bore 220 which is axially displaceable within the bore220. The delivery mechanism 342 also includes a collapsible volume 344bounded by an outside surface 358 of the spool 340, an inside surface252 of the bore 220, the distal seal disposed between the spool 340 andthe bore 220 and a proximal seal 360 disposed and sealed between thespool 340 and the bore 220. The proximal 360 seal is axially fixedrelative to the spool 340 but displaceable relative to an inside surface252 of the bore 220. The slide portion 354 of the spool 340 may bedisposed in a central aperture 362 of the distal seal 346.

An outer surface of the aperture 362 of the distal seal 346 may form asubstantially fluid tight seal over an outside surface 352 of the slideportion 354 of the spool 340, while also being axially displaceable overthe slide portion 354 once the friction there between is overcome. Thedistal seal 346 also forms a seal between an outside surface 350 of thedistal seal 346 and the inside surface 252 of the bore 220 while beingaxially displaceable within the bore 220 once the friction between thedistal seal 346 and surface 252 of the bore 220 is overcome. The slideportion 254 of the spool 340 may be a substantially cylindrical sectionof the spool 340 which as a smooth and uniform outside surface 352. Theslide portion 354 may be bounded at both the proximal end 364 and distalend 366 of the slide portion 354 by a proximal shoulder portion 368 anda distal shoulder portion 370 respectively. The shoulder portions 368and 370 may serve to limit the axial translation of the distal seal 346over the slide portion 354 of the spool 340. The separation of theshoulder portions 368 and 370 may serve to determine the maximum andminimum volume of the collapsible volume 344 of such a spool embodiment340. In some embodiments, the friction between inside surface 252 ofbore 220 and distal seal 346 is greater than friction between outsidesurface 352 of slide portion 354 of spool 340 and aperture 362 of thedistal seal 346.

In some instances, the proximal and distal seals 346 and 360 may includean o-ring. In some embodiments, the spool 340 includes an elongatecylindrical member having a transverse dimension of about 0.5 mm toabout 10 mm, In some cases, the maximum axial displacement of the distalseal 346 between the proximal and distal shoulder portions may be about0.01 inch to about 0.04 inch, more specifically, about 0.018 inch, toabout 0.022 inch. For some embodiments, the bore 220 of the deliverymechanism 342 may have a transverse dimension or diameter of about 0.04inches to about 0.5 inches, more specifically, about 0.08 inches toabout 0.15 inches. For some embodiments, the spool 340 may have a lengthof about 10 mm to about 40 mm, more specifically, about 15 mm to about20 mm. The spool 340 and housing of the delivery mechanism 342 may bemade from any suitable material or materials including polymers orplastics such as polycarbonate, PEEK, thermoplastics, cyclic olefincopolymer, and the like. In some cases, the seals disposed on the spool342 may have an outer transverse dimension or diameter that is slightlylarger than that of the spool 156. In some instances, the seals on thespool 342 may have an axial thickness of about 0.01 inches to about 0.03inches and may be made from materials such as butyl, silicone,polyurethanes or the like having a shore hardness of about 65 A to about75 A, more specifically, about 70 A.

In use, the spool embodiment 340 incorporating the sliding sealarrangement shown in FIG. 19A may operate similarly to the spoolconfiguration 156 shown in FIG. 14 and discussed above. FIG. 19A showsthe delivery mechanism embodiment 342 with the spool 340 in apre-dispense configuration with the collapsible volume 344 disposedbetween the proximal and distal seals 346 and 360 filled with a fluid121 to be dispensed. The collapsible volume 344 of the device may befilled by the same sequence as that shown in FIGS. 14-18 above withregard to spool embodiment 156. In particular, the collapsible volume344 may be distally advanced and positioned to be in fluid communicationwith reservoir inlet port 138. In this position, the collapsible volume344 will be initially in a collapsed state with the distal seal 346 andproximal seal 360 as close together as possible. In other words, thedistal seal 346 would be disposed near or against the proximal shoulderportion 368. The spool 340 may then be proximally retracted so as toproximally retract the proximal seal 360 from the distal seal 346 andthereby expand the collapsible volume 344 drawing the fluid 121 into thecollapsible volume from the reservoir 126 through the reservoir inletport 138.

During proximal withdrawal of the spool 340 and proximal seal 360, thedistal seal 346 may remain substantially stationary with respect to thebore 220 due to the static frictional force between an inside surface ofthe bore and an outside surface of the distal seal 346. This processalso may require that the slide portion of the spool moves axially in aproximal direction through an inner diameter of the annular distal seal346 while maintaining a fluid tight sealed condition therebetween. Itmay also require that the static frictional force between the insidesurface of the bore 220 and outside surface of the distal seal 346 isgreater than the frictional force between the slide portion 354 of thespool and inside aperture or diameter of the distal seal 346. In thisway the spool 340 and proximal seal can translate within the bore 220while the distal seal 346 remains stationary. The proximal withdrawaland filling of the collapsible volume 344 may continue until the distalseal 346 contacts the distal shoulder portion 370 of the spool 340.Thereafter, the spool 340, distal seal 346 and proximal seal 360 may beproximally translated in unison until the collapsible volume is disposedin fluid communication with the dispense port 142.

Once the collapsible volume 344 is disposed in fluid communication withthe dispense port 142, the filling process for the collapsible volume344 discussed above may be reversed. In this case, the spool 340 isdistally advanced along with the proximal seal 360 while the distal seal346 again remains substantially axially stationary. This has the effectof collapsing the collapsible volume 344 and dispensing the fluid 121from the dispense port 142. It should also be noted that for thedispense function to proceed, the frictional force between an outsidesurface of the distal seal 346 and inside surface of the bore 220 mustbe greater than the force equal to the pressure of the fluid 121 withinthe collapsible volume 344 multiplied by the area of the bore 220. Thesame condition holds true for the spool embodiment 156 discussed above.The pressure within the collapsible volume 344 during a dispense cyclemay depend on several factors including the viscosity of the fluid 121,the size and cross sectional area of the various ports 138 and 142, andthe speed with which the spool 340 is translated. For some embodiments,these parameters may be selected such that the pressure of the fluid 121within the collapsible volume 344 may be up to about 20 psi, morespecifically, up to about 10 psi, in some cases. If the pressure of thefluid 121 within the collapsible volume 344 exceeds the force offrictional engagement of the distal seal 346 with the surface of thebore 220, the distal seal will be displaced along with the spool 340, atleast to some extent. The controller of the pump device may beconfigured to measure pressure within the volume of the shell 130 asdiscussed above and detect an increase in pressure during the dispensestroke of the spool 340 or 156. Such a pressure change may be anindication of a clog in the dispense port 142 or fluid lumen of theinfusion kit or line disposed and sealed between the dispense port 142and patient 127. If such a clog is detected, an auditory, vibratory, orvisual signal may be generated to warn the patient of the clog. Allthree types of signals or warnings could be generated as well. Thepressure within the shell 130 may be monitored by the controller 168generally in order to verify the performance of the axial movements ofspool 156 or 340.

FIG. 19B shows the spool 340 after the fluid 121 in the collapsiblevolume 344 has been collapsed by axial translation of the spool 340 andproximal seal 360 while the distal seal 346 has remained substantiallystationary with respect to the bore 220 and dispense port 142. As aresult, the fluid 121 in the collapsible volume 344 has been dispensedfrom the dispense port 142 as shown by the arrow 372 in FIG. 19B. Thespacing of the proximal and distal seals 346 and 360, as well as themaximum and minimum translation of the proximal and distal seals 346 and360 relative to each other may be the same as discussed above withregard to the spool embodiment 156 of FIG. 14. Venting of the ventedvolume 160 of the cartridge 374 may also be carried out in the samemanner with the spool embodiment 340 of FIG. 19A-19E as was discussedabove with regard to venting of the vented volume 160 of cartridge 112.

Referring to FIG. 20, a schematic representation of a portable infusiondevice 380 for delivering a quantity of fluid to a body is shown. Insome embodiments, the portable infusion device 380 may comprise aninsulin or other medicament portable infusion device such as the pumpdevices discussed above. In addition, some or all of the suitablefeatures of the device 380 shown in FIG. 20 may be included with any ofthe pump devices discussed above. The portable infusion device 380 mayinclude a housing 382 which may be of any suitable shape and anysuitable size. For instance, the housing 382 may be extended andtubular, and further may be in the shape of a square, rectangle, circle,cylinder, or the like and may be dimensioned so as to be comfortablyassociated with a user and/or hidden from view, for instance, within orunder the clothes of a user. The housing 382 may be configured toreceive or contain components including one or more of a deliverymechanism 384, a processor 386, a display 388, memory 390, transmitter392, receiver 394, an alarm 396, a speaker 398, a clock/timer 400, andan input device 402. In certain embodiments, the housing 382 may beconfigured for being associated with a removable reservoir 404 and/or aninfusion set 406.

For example, in certain embodiments, the portable infusion device 380includes a delivery mechanism 384. The delivery mechanism 384 may be anysuitable type of mechanism including the delivery mechanisms 90 and 132discussed above. For some embodiments, the delivery mechanism 384 mayinclude a typical drive mechanism, such as a drive mechanism thatincludes a drive screw coupled to a motor. In such an instance, thedrive mechanism may be configured for being operably coupled to areservoir, such as a syringe based reservoir, and the housing may besized to include at least a portion of the drive mechanism and thereservoir. In some instances, the delivery mechanism 384 may include ahydraulics mechanism, pneumatic mechanism, step motor, continuous motor,or the like.

In some embodiments, such as the embodiment depicted in FIG. 21, thedelivery mechanism 384 may include or more of an actuator 408, ashuttlecock 410, and/or one or more trampolines 412. The actuator 408functions to move or otherwise actuate the shuttlecock 410. Theshuttlecock 410 translates within a translation chamber. The translationchamber may communicate with a reservoir, the one or more trampolines,and an outlet orifice. The shuttlecock 410 may be configured such thatas it translates in a given direction, e.g., a forward direction, in thetranslation chamber, a fluid in the reservoir is forced into and throughthe shuttlecock, in such a manner so as to contact one or more of thetrampolines 412, causing the trampoline 412 to extend from a restposition to an extended position. For instance, the trampoline 412 maybe fabricated from a material that is capable of extending in responseto a force, such as the driving force that expels the fluid from thereservoir, through the shuttlecock, and onto a surface of thetrampoline. As the shuttlecock translates in a second given direction,e.g., rearwards, the extended trampoline returns to its rest positionthereby expelling any fluid contained thereon through the shuttlecockand out through a suitably configured outlet.

For certain embodiments, the shuttlecock 410 may be configured such thatas it translates forwards and rearwards within the translation chamber,it regulates the flow of a fluid from the reservoir outwards away fromthe translation chamber outlet 414. The shuttlecock, therefore, can haveany suitable shape or size and be of any suitable configuration so longas it is capable of translating within the translation chamber andthereby regulating the flow of a fluid from the device. In certainembodiments, the shuttlecock has an extended body that includes one ormore openings, which openings pass through the entire width and/orlength of the shuttlecock. The openings may be positioned within theshuttlecock such that they line up with one or more of a correspondingopening in the reservoir and/or the trampoline surface. Hence, as theshuttlecock 410 translates in one direction and at least one openingaligns with a corresponding opening in the reservoir, fluid is expelledinwards through the shuttlecock 410 to contact the surface of thetrampoline 412 causing it to extend thereby storing a quantity of fluidthereon, and as the shuttlecock 410 translates in another direction andat least one opening therein aligns with the extended trampoline 412,the stored fluid is expelled away from the trampoline as it moves towardits rest position, through the shuttlecock 410, and out of thetranslation chamber.

The actuator or drive mechanism 408 may be configured for actuating orotherwise effecting the translation of the shuttlecock 410. The actuator408 may be any mechanism that is capable of causing the translation ofthe shuttlecock 410. For instance, the actuator 408 may include anelectric coil, a ferrite member, a nitinol member, a lever arm,corresponding magnets or electric magnets or dipoles, and the like.

As shown FIG. 22, the portable infusion device 380 may include orotherwise be associated with a reservoir 404. The reservoir embodiment404 may be configured for storing a fluid, such as a liquid or a gas.The reservoir 404 may have any suitable shape and size configured forreceiving and storing a fluid 121 and releasing the same in response toa force, such as an applied pressure. For instance, the reservoir may beconfigured such as those typically known in the art and described above.For example, the reservoir may be a mini-syringe including a barrel forstoring the fluid and a plunger for applying pressure to the fluidwithin barrel which pressure effects the expulsion of the fluid from thebarrel. As indicated above, where a drive mechanism 150 is included, thedrive mechanism 150 may be operably coupled to the reservoir, such asthe plunger, to exert a force in the plunger and thereby effectexpulsion of the fluid from within the barrel. In such an instance, thehousing of the portable infusion device may be configured to contain atleast a portion of the reservoir and/or attendant drive mechanism, e.g.,within the bounds of the housing.

In certain embodiments, such as that depicted in FIG. 22, the reservoir404 may not include a barrel and/or plunger, but rather may include twoor more chambers, such as a first fluid chamber 416, for storing a firstfluid, and a second fluid chamber 418, for storing a second fluid. Thefluid chambers 416 and 418 may be separated one from the other by aliquid gas interface, diaphragm or other moveable boundary 420, suchthat if a pressure is introduced into one chamber and acts upon theboundary that pressure is directly transferred into the other chamber.In certain embodiments, the moveable boundary includes a piston that isconfigured for regulating the interaction between the chambers. Each ofthe fluid chambers may additionally include one or more re-sealable orpregnable seals and/or valves 422 and 424.

For instance, the reservoir 404 may include a first chamber 416 that isconfigured for storing a liquid, such as a medicament to be delivered toa body. The second chamber 418 may be configured for storing a gas, suchas air, carbon dioxide, or the like. The chambers additionally may beconfigured to store the fluid under pressure, such as atmospheric orhigh pressure. The boundary, such as a diaphragm 420, may be made froman elastic material that is substantially impermeable to the fluids ineither chamber, but configured for being displaced from a restingposition to an extended position, such as in response to an increase inpressure. Accordingly, as the second chamber 418 is filled with the gas,the diaphragm 420 is displaced, which displacement causes the pressurein the first chamber 416 to increase. The chambers may include one ormore additional openings for the passage of the fluid into or out of thechamber. For instance, the first chamber 416 may include an opening oregress 426 for allowing the fluid, e.g., a liquid, stored within thechamber 416 to be expelled from the chamber 416 through the egress ordispense port 426.

As indicated above, the egress 426 may be configured so as tocommunicate with the shuttlecock translation chamber and/or shuttlecock410 and/or one or more openings therein. The egress 426 may further beconfigured for opening and closing or otherwise regulating the amount offluid that is allowed to pass there through. In this manner, thereservoir 404 interacts with the delivery mechanism 384 to effectuatethe delivery of a stored fluid from the reservoir 404, through thedelivery mechanism 384, and out of the portable infusion device 380,e.g. via infusion set 406.

In further embodiments, a third chamber may also be included. Forinstance, the third chamber may be in fluid communication or otherwiseassociated with the second chamber, such as via a solenoid valve. Incertain embodiments, the reservoir is configured in such a manner thatthe amount of fluid delivered by the first chamber is directlycalculated by a transfer of an amount of gas, e.g., from one chamber toanother, such as by the amount of gas transferred from the third to thesecond chamber.

For example, the total volume of the second and/or third chambers may befixed. As gas is transferred from the third chamber to the secondchamber, an increase in volume in the second chamber results in acorresponding decrease in volume of the third chamber. This transfer offluid results in a pressure being exerted on the diaphragm resulting inthe expulsion of fluid from the first chamber, wherein the amount offluid expelled from the first chamber is directly proportional to theincrease in volume of the second chamber. Sensors may be included in thesecond and third chambers so as to determine the pressure transfer ofthe gas in the second and third chambers.

Specifically, since the volume of the third chamber is known and fixed,the ideal gas law and the principle of conservation of mass may beapplied to determine the volume of gas in the second chamber. Since thecombined volume of the second and first chambers is known and fixed, thevolume of the first chamber is determined from the calculated volume ofthe second. The flow rate of the fluid from the first chamber isdetermined by calculating the volume of fluid in the second chamber attwo instances in time and dividing the change in volume by the timebetween measurements. See, for instance, U.S. Pat. No. 7,374,556incorporated by reference herein in its entirety. The processor may beemployed for determining the dispensing of fluid from the first chamber,based upon the pressures sensed by the pressure sensor(s), e.g., in thesecond and third chambers. See, for instance, FIG. 23.

As indicated in FIG. 22, the chambers 416 and 418 of the reservoir 404may include one or more seals and/or valves e.g. 422 and 424, such as asolenoid valve. The seals and/or valves may be configured for allowing afluid to be added to a lumen of the chamber, thereby allowing thepassage of the fluid into the chamber, while at the same time preventingthe passage of the fluid back out of the chamber, once the fluid hasentered into the chamber. In certain embodiments, a valve is includedwherein the valve is capable of regulating the flow of the fluid intoand/or out of the chamber, for instance, in a controlled manner.

Further, as indicated in FIGS. 20 and 22, the reservoir 404 may includea housing 428, wherein at least partially within the bounds of thehousing the first and second chambers 416 and 418 are contained. Thehousing may be coextensive with the housing of the portable infusiondevice, or the housing 428 of the reservoir 404 may be separate therefrom, e.g., a separate and distinct component. For instance, asdepicted, the housing 428 of the reservoir 404 is a separate componentfrom the housing 382 of the portable infusion device 380. For example,the housing 382 of the portable infusion device 380 may include anattachment mechanism 430A and 430B, and the housing 428 of the reservoir404 may include a corresponding attachment mechanism 432A an 432B,wherein the attachment mechanisms are configured for interacting withone another in such a manner that the housing 382 of the portableinfusion device 380 is capable of being removably coupled to the housing428 of the reservoir 404, thereby allowing the reservoir 404 to beattached and detached from the portable infusion device 380.

The attachment mechanism may have any shape and configuration, that iscapable of removably attaching the housing 428 of the reservoir 404 withthe housing 382 of the portable infusion device 380. In certainembodiments, the attachment is a rail system including correspondinggrooves that allow the reservoir to be slidably coupled to the portableinfusion device. In other embodiments, the attachment is a snap systemthat includes corresponding male and female parts that allow thereservoir to snap into place in operable contact with the portableinfusion device. Hence, in certain instances, the reservoir and/orassociated housing form a removable cartridge. Further, in certainembodiments, the reservoir itself is a cartridge that fits into aseparate reservoir housing, which housing may then be attached, e.g.,removably, to the housing of the portable infusion device.

As shown in FIG. 23, the portable infusion device 380 may include aprocessor 386. The processor 386 functions for controlling the overallfunctions of the portable infusion device 380. Specifically, theprocessor 386 includes programming that functions to control the device380 and its components. The programming may comprise computerinstructions stored in memory or firmware components that, when executedby the processor 386, provide the processing and features describedherein. For instance, the processor 386 may communicate with, e.g., sendsignals to and/or receives signals from, and/or otherwise control one ormore of the delivery mechanism 384, reservoir 404, estimators 434,output mechanisms (e.g., display) 388, memory 390, transmitter 392,receiver 394, alarm(s) 396, speaker 398, clock 400, and the like. Theprogramming that is executed by the processor 386 may be referred toherein as the “program” or “programming” of the device.

Accordingly, the processor may include programming that it can executeto control the speed of shuttlecock translation, the release of fluidfrom the reservoir, the data to be displayed by a display, the data tobe transmitted via the transmitter, the one or more alarms, etc. Theprocessor may also include programming that allows the processor toreceive signals and/or other data from an input device, receiver,various sensors (such as a sensor that may be included as a part of thedevice or used in conjunction therewith, for instance, a blood glucosemonitor and/or a blood glucose sensor, and the like) and to store thesame in a memory. The memory can be any type of memory capable ofstoring data and communicating that data to one or more other componentsof the device, such as the processor.

For instance, the memory may be one or more of a Flash memory, SRAM,ROM, DRAM, RAM, EPROM, dynamic storage, and the like. For instance, thememory may be coupled to the processor and configured to receive andstore input data and/or store one or more template or generated deliverypatterns. For example, the memory may be configured to store one or morepersonalized (e.g., user defined) delivery profiles, such as a profilebased on a user's selection and/or grouping of various input factors (asdescribed below); past generated delivery profiles; recommended deliveryprofiles; one or more traditional delivery profiles, e.g., square wave,dual square wave, basal and bolus rate profiles; and/or the like. Thememory may also be configured for storing user information, history ofuse, compliance, an accessible calendar of events, and the like.

The processor may also include programming to allow the processor tomake a recommendation. For instance, the processor may include one ormore estimator functionalities 434 that enable the processor 386 toreceive data from various sources, parse the data, collate the same, andgenerate an estimate based on the same. For instance, the processor maybe configured to receive user input data and/or data from one or moresensors or other external source, which data the processor can processand thereby use to generate an estimate, such as an estimate of anamount of fluid to deliver to a body, a rate of fluid delivery, and/or aspecific fluid delivery profile. For example, the processor may beconfigured to process data pertinent to a current or predicted conditionand to generate an estimate, represented as an amount, rate, profile,etc. of fluid to be delivered based on that data, which estimate maythen be displayed to a user, thereby allowing the user to interact withthe estimate to accept, decline, and/or otherwise modify the estimate.

Specifically, as shown in FIG. 23, the processor 386 receives inputsfrom many of the other various components of the device 380. Asindicated above, the portable infusion device may include one or moresensors, such as one or more pressure sensors 436A and 436B, atemperature sensor 438, a clock 400, and the like. For instance, asindicated above, the processor 386 may be configured for receivingpressure sensor data, which data may be processed to determine a flowrate 440 and/or further used to control a flow regulator 442 (e.g., avalve of the reservoir, a motor of the actuator) so as to make flow rateadjustments 442 and/or recommendations of the same for userconsideration and evaluation. For example, the processor may receivepressure data from the sensors, e.g., pressure sensors 436A and 436B,which may be included in the second and third chambers (if included),and use that data to determine an amount of fluid being delivered fromthe device and/or a flow rate, which data in turn may be used toregulate and/or otherwise adjust the rate of flow, for instance, bycommunicating with one or more solenoids associated with the chamberse.g., through various electronic switches controlled by the processor.

For instance, the processor 386, and other processors discussed herein,may include estimator programming 434, such as estimators A-E (or alarger number as desired), enabling the processor 386 to adjust theamount and/or flow rate, etc. of a fluid from the device 380. Forexample, the portable infusion device 380 may include an interface thatallows a user such as a patient to interact with the programming of theprocessor to determine an amount of fluid to be delivered, a rate ofdelivery, a delivery profile, and/or the like. In certain embodiments,the portable infusion device is configured for receiving userinformation about a users present or predicted conditions. Suchinformation may include the amount of insulin already present in thebody, e.g., insulin on board; blood glucose level; trending glucoselevel; insulin sensitivity/insensitivity; glycemic index; metabolism;metabolic rate; stress level; physiological conditions, e.g., age,health, sickness, diurnal cycles, etc; measurable parameters: hormones,steroids, etc.; pharmacokinetics of the medicament, e.g., age ofinsulin, decay rate, etc.; food to be ingested, e.g., carbohydrates,proteins, fat; activity; use history; calendared events; environment,e.g., temperature, humidity, pressure, etc.; and the like. One or moreof these factors may be entered into the device, for instance, by aninput device. The processor 386 includes programming configured forreceiving such user input information, such as that discussed above,parsing and collating the information to generate an output, andpresenting that output to a user, such as on display 388.

As can be seen with respect to FIG. 24, the portable infusion device mayinclude a display 388, which display may be operable through aninput/output interface. The display 388 may also include an input device402. The display 388 may be any form of display capable of receivingdata from the processor and displaying that data, for instance,receiving the data through an interface and displaying the data on adisplay screen, e.g., an LCD, LED, and/or plasma screen. The display 388may be an interactive display and include a screen 448, wherein thescreen may further include a touch screen, or touch sensitive, inputdevice 402. For instance, the screen may be a capacitance or resistivetouch screen.

A unique complication that may be present with respect to diabetic usersis that they often build up calluses on the tips of their fingers as aresult of blood glucose testing, which may be problematic forcapacitive-based touch screen configurations. For example, calluses mayprevent or hinder the transfer of energy that the capacitive screens useto receive directions. Accordingly, in certain embodiments, the touchscreen may be a resistive based touch screen. The touch screen, or touchsensitive display, may be configured to display screens or pages thatallow the user to input data fields, e.g., select variable inputs, so asto allow the program to produce a suggested delivery amount, rate,profile, and/or the like in an intuitive, manipulable, and/or graphicrepresentation, thereby allowing the user to interact with the screen toshape the characteristic/form of the delivery amount, rate, and/orgraphic delivery profile, e.g., by manipulating the delivery estimate orpattern displayed on the screen to effectuate the actual delivery. Theportable infusion device may additionally include a keyboard or otherdevice known in the art for data entry, which such devices may beseparate from the screen and/or display.

Information provided by the portable infusion device may be presented onthe display screen as any number of objects, including one or morenumerical values, a range, a value or range that is presented in theform of a drop-down menu, a toggle that can be adjusted by the user, agraphical representation or an animated graphic, and the like. Forinstance, in certain embodiments the value is a range of values that arepresented on a screen of the display as a toggle, wherein the toggle maybe adjusted upwards or downwards by the user swiping a finger over thescreen to select the appropriate value range, e.g. appropriate range ofamounts of medicament such as insulin to be delivered and/or theappropriate rate of medicament delivery. In certain instances, thevalues presented in the range may be adjusted by the processor 170 basedon various characteristics of the user, such as age, sex, weight,height, insulin sensitivity, etc.

Additionally, in certain instances, the value estimate may be displayedin graphical form; for instance, as an interactive graphic interface,such as where the value to be displayed is a delivery profile. In somecircumstances, a possible advantage of the disclosed portable infusiondevices is that the programming of the processor and the touch screenfunctionality permit the portable infusion device to receive user inputspertaining to a wide variety of variables, such as those describedabove. The variables may be used to generate a graphic representation ofa delivery profile that may be manipulated by the user to change thedelivery profile, with or without various predetermined parameters. Thisrepresents a movement away from the static stair step delivery modulesthat are based more on the limitations of archaic pumping mechanisms andthat have a limited ability to correlate with the actual present orfuture medicament needs of a user. Hence, rather than locking a userinto a delivery profile that resembles, for example, a square stair stepwave or a dual wave profile, as is commonly employed in the art, thedelivery profiles of the present portable infusion device may berepresented as a series of adjustable graphs.

For example, where the fluid to be delivered is insulin, a portableinfusion device of the present disclosure may be configured to receiveuser and/or external, e.g., sensor, inputs to calculate current orpredicted insulin on board for the user, and may further makecalculations to determine a predicted rate of decay for the same. Theportable infusion device programming may in turn use this information,along with other information, such as user input information, e.g.,current blood glucose level, stress level, or activity level, togenerate a delivery profile that more resembles the actual insulinrequirements of a user. In this manner, a portable infusion device ofthe present disclosure generates a delivery profile that models theamount of glucose in the blood, such that a user will have enoughinsulin to deal with the present blood sugar but not so much of anexcess that medical complications arise.

Specifically, in many current infusion pumps, two typical infusion ratesare possible: a basal rate, wherein insulin is being delivered at aconstant rate; and a bolus rate, wherein prior to ingesting food a bolusof insulin is delivered to account for the amount of sugar to beingested. In practice, the user enters the amount of carbohydrates theyare about to ingest, their carb ratio (the volume of insulin programmedto be delivered for every particular number of carbohydrates predictedto be consumed by the user), and based on this information the infusionpump will generate an estimate of a bolus amount of insulin to bedelivered. If accepted by the user, e.g., by depressing a button, thethen-current basal delivery mode is suspended and the bolus deliveryrate is initiated.

As discussed, there are several shortfalls in such calculations. Forinstance, the amount of insulin to be delivered should model the amountof glucose in the blood as well as the predicted amount of glucose to beingested, and/or the insulin sensitivity of the user. These amounts arefurther affected by factors such as the user's emotional state, activitylevel, physical conditions, etc; and further, the food to be ingestedoften include other components, e.g., fat and protein, in addition tocarbohydrates, which are generally not of high importance in thecalculations performed by current devices. Although the presentlydisclosed portable infusion devices consider the amount of carbohydratesa user is to ingest as well as their carb ratio, they also may considera wide variety of other variables that may be input by the user or otherexternal sources, such as by sensors, and the like. That is, thesuggested delivery profile that is generated by the processor mayinclude as input values such as amount of carbs, user carb ratio, user'semotional state, activity level, physical conditions, etc. Hence, thesuggested delivery profile that is produced by a portable infusiondevice of the present disclosure more closely represents the amount ofinsulin to be delivered over time at the time that amount of insulin isexpected to be needed, thus more closely matching the amount of insulinon board at any given time with the amount of glucose present in theblood for that time.

Therefore, rather than merely having two basic delivery modes orprofiles, such as a basal delivery profile that may be suspended andreplaced by a bolus delivery profile, e.g., prior to when a user isabout to eat, the delivery profiles of the present portable infusiondevices may include a plurality of bolus delivery profiles that may beused in any combination to deliver a series of boluses. These profilesmay be adjusted over time to account for a changing variety of variablessuch as insulin on board, food ingested, decay rates for both theinsulin on board and insulin delivered, carb ratio, and the like. Theboluses may be of equal size or of different sizes, in accordance withthe delivery profile. In this manner, the present portable infusiondevices are capable of more closely controlling the level of insulin inthe bloodstream, and generating delivery patterns that resemble actualinsulin needs rather than delivery patterns that are based on thelimitations provided by the pump's mechanical delivery mechanisms.

For instance, due in part to their unique delivery mechanism(s) and/orprogramming, the portable infusion devices of the disclosure may beconfigured for delivering a series of multiple reduced size bolusdeliveries of a fluid, such as insulin, so as to finely control theamount of that fluid in the blood, e.g., the amount of insulin on board(IOB). Thus the total amount of the fluid, e.g., insulin, delivered isan integrated amount determined by the graphical shape of the deliveryprofile curve for the series of multiple bolus deliveries. For example,the graphical shape of the delivery profile curve may represent theamount of insulin delivered over a period of time, where the x-axis ofthe graph represents the time, e.g., hours, minutes, actual time inuser's time zone, etc., and the y-axis represents the amount of insulin,e.g., in units. Therefore, the rate of insulin delivery may be easilyrepresented by a graph having a slope defining the delivery rate and thearea under the graph totaling generally the amount of fluid delivered,or to be delivered, to the user. Hence, in this manner, the portableinfusion device may more closely control the fluid, e.g., the amount ofthe medicament, such as insulin, in the user's blood stream by generallyconstantly modulating the boluses of the fluid being delivered. Inaddition, or alternatively, the modulation of boluses may be done on anon-constant basis, e.g., rapidly, intermittently, periodically, etc.,as generally desired by a user.

The mechanisms, processors, and programs employed by current infusionpumps cannot account for the data input and/or to make the calculationsand determinations sufficient to enable fine manipulations of thesuggested delivery profile(s). Accordingly, although portable infusiondevices described herein are capable of generating square or dual wavebolus delivery patterns, because of the dynamics of the systemsdescribed herein, such patterns are capable of being manipulated, evenin real-time, by a user via, e.g., a touch screen display, so as to beadjusted according to any of a number of variables, as described above.For example, due in part to the programming of the present devices, theportable infusion devices described herein may calculate necessaryvolumes of insulin to deliver to a user in order to at least attempt tomaintain a user's target blood glucose level, which is generated byaccounting for various parameters entered by the user or externalsources.

In this manner, for instance, with respect to insulin, a desired idealdelivery profile may be generated so as to match the insulin to bedelivered with the amount of glucose in the blood given the present orpredicted future conditions of the user taking into account suchparameters as meals, meal complexities, exercise, absorption/clearancerates, decay rates, and the like. A benefit of the programming describedherein may be that it allows for predicted events and provides forreal-time corrections to medicament delivery if those predicted eventsso not correlate with or anticipate current conditions. Thus, thedevices disclosed herein allow for generally predictive events so thatan appropriate amount of insulin can be available in the blood at thetime needed to account for the changing conditions of the user, and/orcan be corrected real time. For example, the present devices allow foran estimate of medicament amount, rate, profile, etc. that will beneeded in the future so that an appropriate amount of the medicament,e.g., insulin, needed to accomplish a desired function, such as processthe now current glucose present in the blood, is generally readilyavailable to the user.

Specifically, in some exemplary situations, the user may input data intothe device pertaining to a meal to be consumed. The processor willprocess that information to generate an insulin delivery pattern,wherein the amount of insulin to be delivered is modeled on thepredicted amount of glucose to be present at the time of its enteringthe bloodstream based on the inputted data and/or data accessed via thememory or remotely via, e.g., a network, for calculating the amount ofinsulin required. Hence, in such a situation, the portable infusiondevice system may account for such variables as the type and amount offood to be ingested, the amount of glucose, other sugars andcarbohydrates, proteins and fat associated with such food, the decayrate of insulin, as well as the rate at which the food ingested ismetabolized by the body for the food ingested. The data to be enteredinto the system of the device, therefore, may include one or more of thecomplex composition, as described above, of the meal (e.g., which may bea value range based on low, medium, or high complexity), and/or mayinclude the amounts of carbohydrates, proteins, and fats to be consumed.The users current blood glucose level and/or glycemic index may then beinput or may be calculated, the insulin duration and/or food (e.g.,carbohydrate, protein, fat) absorption rates may be calculated, currentor predicted activity levels, and variables related to presentphysiological conditions (e.g., stress levels) may be input into thedevice, any or all of which data may be used by the processor togenerate a delivery profile that more closely represents desirable orideal curve for insulin on board (IOB) over time, which is the amount ofinsulin remaining in a user's body over time due to any bolus deliveriesof insulin to the user. The delivery profile generated may then beaccepted and/or manipulated by the user, for instance, in an exemplarysituation where the user predicts that he or she will be exercisingwithin a certain period of time but never does. Accordingly, thedelivery profile may be represented as a graph, such as a graph thatdisplays the amount of insulin to be delivered over time, which graphmay be capable of being graphically manipulated by a user.

For instance, the graphic representation may be a bar graph thatindicates an amount of insulin to be delivered over a certain timeinterval, such as a four minute increment, for a given period of time,e.g., 1 hour, wherein each bars represents an aliquot of insulin to bedelivered within the 4 minute time increments, and the height of the barequals the amount of insulin to be delivered within that time frame, andfurther wherein the height of the bars may be manipulated by a user inresponse to present or predicted conditions. For example, in oneembodiment, a series of bolus amounts of insulin to be delivered e.g.,every four minutes, for a given time period, e.g. 1 hour, may becalculated, wherein the upper limit for the total amount of insulin tobe delivered is fixed, but each individual bar, representing an amountof insulin to be delivered in a given 4 minute increment, is adjustablewithin a given range, so as to allow a user to have greater control ofthe amount of insulin being delivered over the given time period.

In some instances, a first graph may be displayed wherein the user isnotified of the amount of insulin that is presently “on board” andexpected to be “on board” over a given time period. A second graph maythen be displayed showing a suggested amount of insulin to be deliveredover a given time period, e.g. overlaid with the first graph or shownsequentially thereafter. The shape of this second graph may be capableof user manipulation, if desired. In certain embodiments, the systemsdisclosed herein may allow for complete manipulation of medicamentdelivery by a user with no limits, or, for safety and/or regulatoryreasons may provide a range of data within which the medicament deliverymay be so manipulated or altered. The user may, e.g., be prompted beforemaking any or all such changes if they, for instance, calculated by thesystem to be dangerous, non-optimal, etc., such as with a messageprompting the user to select a button before making such change and/orreading a message with information regarding possible effects of suchmanipulation before making such change. Alternative “lock out” featurestemporarily disabling the ability for such manipulation may be used aswell as alarms or notification functionality for storing and/ortransmitting data associated with such user-generated changes to aclinician, parent, etc. In some embodiments, although the shape of thegraph is capable of being manipulated so as to change the deliveryprofile, the total area under the curve, and therefore the total amountof insulin to be delivered over time, is not changed.

In other embodiments, as indicated above, the graph may be a series ofbars, wherein the width of each bar represents a time period, the heightof each bar represents an amount of insulin to be delivered, and thenumber of bars represent a given time period for delivery. In such aninstance, each individual bar may be capable of being manipulated, andin certain embodiments, the total amount of insulin to be delivered forthe overall period could be limited such that an increase in one barresults in an a subsequent decrease in another bar for the given overallperiod. Additionally, a bar graph could be displayed wherein the insulinon board is represented as a function of activity, wherein the barsrepresent the amount of suggested insulin to be delivered, e.g., in 4minute increments, and the bars are capable of being manipulated withrespect to the amount of exercise to be engaged in. In such an instance,a decrease in activity level may require an increase in the amount ofinsulin to be delivered.

In another embodiment, the graphic representation may be a trianglebounded by three points that are variably selected, e.g., food to beingested, historic blood glucose level, and activity level, wherein theoutput would be a given amount of glucose to be delivered over a givenperiod of time, and further wherein the shape of the triangle may bemodulated by the user to change the delivery profile. In a furtherembodiment, a delivery rate may be set forth graphically in a series ofstep, the steps could then be overlaid by a suggested rounded wave, andthe user can manipulate the screen so as to configure the steps to modelthe shape of wave, e.g., rounding out the steps.

It is to be noted that although the above examples have been set forthwith respect to the amount of insulin to be delivered in view of certainvariables, such as time, activity level, user history, and the like,equivalent graphical representations could be set forth with respect toany of the above described variables. Further, although variousgraphical representations have been set forth, such as generallywave-from shaped graph, bar graphs, and generally triangular shapedgraphs, such graphical representations are not meant to be limitedhereby as other graphical representations could be used to convey therelationships between the various factors herein, and thus, thedisclosed graphical representations are not meant hereby to be limiting.

As indicated above, the graphical representations are capable of beingmanipulated, for instance, by a user interacting with the device in sucha manner as to produce a change in a characteristic of the graph. Forinstance, where the screen of the display is a touch screen, or touchsensitive display, the user may interact with the screen, e.g., by useof a finger, stylus, or other such instrument, so as to cause a changein the displayed representation. Hence, in certain embodiments, thedisplay may be configured in any suitable manner that allows for therepresentation of data, which data may then be acted upon by a user soas to effect a change in the displayed representation. For example, incertain embodiments, the display is configured for displaying variousforms of graphs, which graphs may be capable of being manipulated by auser's interaction therewith. Additionally, in certain embodiments, thedisplay is configured for displaying a toggle representing a givenquantity, which toggle may be scrolled through for the selection by theuser of a determined representation of the quantity to be selected.

For instance, where the display is configured for graphicalrepresentation, the graphic representation may be configured formanipulation by a user touching or otherwise “clicking” therepresentation and dragging the representation in a predefined manner soas to change the form, e.g., height, width, shape, etc. of therepresentation. For example, where the graphical representation is abar, the height or width of the bar may be adjusted by clicking on theappropriate dimension and manipulating it to adjust that chosendimension. Where the graphical representation is a curve or wave, thecurve or wave may be clicked and the shape thereof may then bemanipulated, for instance, by dragging a finger across the screen in apredetermined manner. As the graphical curve or wave is manipulated bythe user, data values corresponding to the curve values are changed.

FIG. 54 illustrates an example of multiple graphs being simultaneouslydisplayed on the touch screen display, which include a BG graph, an IOBgraph and a target BG graph. Any one of the graphs may be configured formanipulation by a user, such that a user may modify the slope of any oneof the graphs in order to ultimately modify the rate amount of insulinin the body of the user over a period of time. Furthermore, usermanipulation of one graph may or may not automatically causemodifications to one or more additional graphs and/or settings. Anynumber of graphs displaying various data may be simultaneously displayedon the touch screen display to enable a user to directly modify any oneof the displayed modifiable graphs.

Some embodiments may include a configuration wherein the graph includesa handle and spline, wherein the graph is capable of being manipulatedby tapping the handle and moving the same to effect a change in thespline. Hence, in such manners as these, the graphs of the display, incertain embodiments, are capable of being manipulated, which allows auser to change, e.g., in real time, the delivery pattern of a fluid, forinstance, so as to account for present conditions and/or futurepredictions, such as actual exercise levels and/or actual amounts to beeaten vs. predicted exercise levels and/or amounts actually eaten. Incertain embodiments, the graphic representations may also include anauto correct feature, such as a feature that allows for a best-it curvecorrection, such as, e.g., an auto correct button.

Accordingly, the device may receive information from a user input and/orsensor or monitor input and based on this information may make acalculation of an amount of glucose present or about to be present inthe blood. The results of these calculations can then be used generatean amount or rate of insulin to be delivered over a given period oftime, which rate may be represented as a graph, such as a graph that canbe manipulated by the user. Once the suggested amount, rate, deliveryprofile, or the like is presented to the user, the system may requirethe user to take an affirmative action, such as depressing aconfirmation screen, before the device will deliver the medicament inresponse to the user's affirmative action.

For instance, in some exemplary embodiments, as can be seen with respectto FIG. 25, the processor 386 may be configured for receiving user input402 as well as sensor input 438 and generating an output 446A, such asan estimated amount or rate of fluid to be delivered, which output maybe presented on a display of the device, such as in a toggle or graphicformat. The output 446A may further be of such a configuration that auser response may be required, for instance, by tapping a screen of thedisplay as, for instance, selecting an object or symbol of the displayto indicate a confirmation of the user's acceptance of the estimate,which confirmation serves as additional user input 446B that signals theprocessor 386 to initiate the delivery mechanism 384 so as to translatewithin the translation chamber and the reservoir 404 to expel fluid intothe translation chamber and thereby begin delivery of the fluid inaccordance with the confirmed amount and/or rate. As indicated above,the reservoir 404 may include one or more sensors that can send theprocessor information with which the processor can determine the amountand rate of delivery and adjust the same as necessary in accordance withthe user instructions, thus, allowing a feedback loop whereby theactuator may be deactivated and/or the egress of the reservoir closedonce the appropriate amount of fluid has been delivered. Otherselections of objects and symbols on the display may provideconfirmation of selection or acceptance of the corresponding displayedvalues of the object or symbol.

The portable infusion device 380 of the disclosure may also include oneor more of a suitably configured power source; wire or wirelesscommunication capability, such as for the remote sending and receivingof data, e.g., a transmitter and/or receiver, WIFI connection, infraredor bluetooth communication device, USB or SD port, flash drive port, orthe like; GPS functionality; phone functionality; warning and/or alarmprogramming; music storage and replay functionality, e.g., an MP3player; a camera or video mechanism; auto scaling capabilities, and/orone or more video type games. A USB connection may be used to charge thedevice and may allow the portable infusion device to display informationfrom a program being run by the processor on the device onto theconnected computer's monitor. Therefore, this may allow a portableinfusion device to interact with any computer having a USB connector forat least downloading data onto the computer for subsequent use of thedata, e.g., upload onto the internet, save data in computer's memory,view and/or modify device data using word processing, store the data invarious media file formats, etc. This also relieves users from having toload installation software onto a computer prior to at least downloadingdata from the portable infusion device onto the computer.

The device may also include an accelerometer, for instance, which may beused for changing presented estimates, wherein instead of scrollingthrough a menu of options or using a numerical keypad, values can beinput or changed via the accelerometer, such as by gesturing with orotherwise shaking the device. Further, the processor of the device mayinclude additional programming to allow the processor to learn userpreferences and/or user characteristics and/or user history data, forinstance, to implement changes in use suggestions based on detectedtrends, such as weight gain or loss; and may include programming thatallows the device to generate reports, such as reports based upon userhistory, compliance, trending, and/or other such data. Additionally, adevice of the disclosure may include a power of or suspend function forsuspending one or more functions of the device, such as suspending adelivery protocol, and/or for powering off of the device or the deliverymechanism thereof.

Some embodiments of an infusion system may include a portable infusiondevice, as described above and a remote commander device. In such aninstance, the portable infusion device may include a suitably configuredreceiver and/or transmitter for communication with an external devicesuch as a remote commander, as well as programming for directing the useof the device; and the remote commander may additionally include asuitably configured receiver and/or transmitter for communication withan external device such as a portable infusion device, as well asprogramming for directing the use of the device. For instance, theremote commander may include one or more of the functionalitiesdescribed herein above with respect to the portable infusion device.

For example, the remote commander may include a processor, a memory, atransmitter and/or receiver, an input mechanism, an output mechanism,e.g., a display, a clock, a timer, an alarm, an estimator, and the like.Hence, in certain embodiments, the portable infusion device may includea transmitter that receives commands, e.g., infusion commands, from theprocessor and transmits the commands (e.g., to a remote commander orvice-versa). Similarly, the remote commander may include a transmitterthat receives commands, e.g., infusion commands, from its processor andtransmits the commands (e.g., to a portable infusion device orvice-versa). In such an instance, the portable infusion device and/orremote commander may also include a receiver that receives commands,such as remotely/wirelessly generated commands, and communicates thecommands to the processor. Accordingly, the remote commander may includethe appropriate hardware and software necessary for producing thesefunctionalities in the remote commander, such as that described abovewith respect to the portable infusion device. The portable infusiondevice itself or the remote commander may also include programming thatincludes an initiating command request, whereby the user has to interactwith the device, such as by tapping a screen, e.g., on a display of theportable infusion device or remote commander, so as to accept aninfusion recommendation before the remote commander signals the portableinfusion device and/or before the portable infusion device accepts thecommand and begins infusion of the fluid.

Some embodiments may be directed to a system for generating an estimateof an amount of fluid to be delivered to a body and for delivering theamount of fluid to the body of a user in accordance with the generatedestimate. The system may include a remote commander and a portableinfusion device. For instance, the system may include a remote commanderconfigured for generating the estimate of the amount of fluid to bedelivered to the body, and for communicating instructions for thedelivery of the amount of fluid to the portable infusion device.Accordingly, the remote commander may include one or more of: aprocessor, for generating an estimate of an amount of fluid to bedelivered to a body in response to user input data; a data inputinterface for communicating with the processor, wherein the data inputinterface is configured for receiving user input data; a memory coupledto the processor; for receiving and storing user input data; a displayfor displaying the estimate of an amount of a fluid to be delivered; anda transmitter for transmitting a command to a portable infusion device,wherein the command instructs the portable infusion device to deliver anamount of fluid in accordance with the generated and confirmed estimate.

Further, the system may include a portable infusion device that isconfigured for delivering the amount of fluid to the body in accordancewith the estimate generated by the remote commander. The portableinfusion device may include one or more of a reservoir, for storing thefluid; a delivery mechanism, for effecting the delivery of the fluid; areceiver for receiving instructions, e.g., commands, from thetransmitter of the remote commander; and a processor, for instructingthe reservoir and/or delivery mechanism to deliver the amount of fluidto the body of a user in accordance with the received instructions,e.g., the generated estimate.

Additionally, the housing of the device, e.g., the housing of theportable infusion device and/or reservoir and/or remote commander (ifincluded), may be configured for containing at least a portion of one ormore of a stylus, a lancet, and/or glucose sensing strips or otherglucose sensing components. Additionally, the device may include aremovable skin or other cover configured for protecting the device fromthe environment and/or breakage due to mishandling. One or more of thesemay also be included in a kit of the present disclosure.

Some embodiments may be directed to a method for using the aboveportable infusion device and/or remote commander so as to deliver anamount of a fluid, such as an estimated amount of fluid to a body of auser. The method may include providing an infusion device and/or remotecommander, as described above, for instance, where the infusion deviceincludes one or more of a reservoir, for storing the fluid; a deliverymechanism, for delivering the fluid; a processor, for generating anestimate of an amount of fluid to be delivered to the body in responseto user input data, and for controlling the delivery mechanism; a datainput interface for communicating with the processor, wherein the datainput interface is configured for receiving user input data; atransmitter and/or a receiver, for transmitting and receiving commands;and a display for displaying the estimate of an amount of a fluid to bedelivered. If a remote commander is provided, the remote commander mayinclude one or more of a processor, for controlling the remote commanderand/or generating an estimate of an amount of fluid to be delivered tothe body in response to user input data; a data input interface forgenerating commands and communicating with the processor, wherein thedata input interface is configured for receiving user input data, suchas a user command; a transmitter and/or a receiver, for transmitting andreceiving commands; and a display for displaying the command and/or anestimate of an amount of a fluid to be delivered.

The method may further include inputting externally supplied values intothe data input interface, such as a data input interface of the portableinfusion device and/or remote commander wherein the data input interfaceis configured for receiving the user input data and communicating thatdata to the processor and the processor is configured for receiving theuser input data and/or generating an estimate of an amount of a fluid tobe delivered to the body of the user, and further configured forcommunicating the estimate to the display and/or to the portableinfusion device or remote commander (if included). For instance, theuser input data may include one or more of a blood glucose level, astress level, a physiological condition, a complexity of a meal to beingested, an activity level, a user history profile, or the like. Themethod may additionally include one or more of receiving the generatedestimate of an amount of fluid to be delivered on a display of theportable infusion device and/or remote commander; receiving a requestfor a user input on a display of the device, such as wherein the requestrequires the user make a selection before delivering the amount of fluidto the body of the user; and making a selection based on the estimate;wherein, once the selection is made (if required) the device deliversthe quantity of fluid to the body in response to the selection.

Some embodiments may be directed to a kit which kit may include a deviceand/or a system for the infusion of a medicament as described hereinabove. Specifically, the kit may include one or more of a portableinfusion device, a reservoir, a remote commander, as well asinstructions for using the same, and may include an aliquot of themedicament, e.g., insulin to be delivered, as well as infusion settubing. The instructions may be in written, audio, or pictorial form andmay be included in a written manual and/or on an instruction CD or DVD,MP3 file, or accessible via a network. In certain embodiments, atraining video may be included, for instance, on a separate DVD or othermedium, may be accessible via a network, or may be included asprogramming on the portable infusion device and/or remote commander. Forinstance, in certain embodiments, the portable infusion device and/orremote commander may include a training module. The training module maybe included as programming accessible by the processor of the device,wherein the software is configured to instruct a user in the proper useof the device.

In certain embodiments, the programming may be interactive, thus, thesoftware may include steps of tasks (e.g., such as loading a reservoir,entering data, or using an estimator) that must be accomplished to showmastery of the use of the device and/or may include additionalprogramming that prevents a user from moving on to the next step beforemastering the present steps, such programming may be automaticallyerasable after the tasks of the steps have been completed therebyexpanding available memory. The programming may include one or more ofan automated mascot, an electronic protocol, preloaded or downloadablevideo training, as well as instructions for how to use the device and/orspecific features of the device. Additionally, the remote commanderand/or portable infusion device may include one or more indicatorsand/or alarms, such as an alarm that indicates when a command, e.g., auser input, is being received, has been received, and/or is being or hasbeen implemented by one or both of the remote commander and portableinfusion device. The indicator and/or alarm may be a visual indication,auditory indication, tactile indication, and the like.

It should be noted that some or all of the suitable features,dimensions, materials and methods of use of the GUI 166 may be used orincorporated into any other infusion system, or components thereof,discussed herein. As discussed in an embodiment above, the screen of thedisplay 450 may be a touch screen 450. For example, a touch screen 450may have a 320×240 pixel QVGA display, 16 bit color depth, and arectangular shaped display area having a diagonal length of 2.5 inches.However, the touch screen 452 display 450 of the portable infusiondevice 110 may have any variation of display characteristics andconfigurations, e.g., 128×64 to 1280×1024 pixel resolution, 16 to 32 bitcolor depth, and a diagonal display 450 length of 1 to 3 inches. Theuser may interact with the touch screen 452 by touching the touch screen452 (e.g., by use of finger, stylus, or other such instrument), so as tocause a change in the display representation. The user-interactive touchscreen 452 also assists in providing the user with a user-friendlygraphical user interface (GUI) 454, which can be used in GUI 166 in theembodiment discussed above. In addition, the GUI 454 may be used incombination with any of the infusion device embodiments described hereinfor controlling the delivery of one or more fluids to a user, orpatient. User-friendly GUI 454 embodiments discussed herein may includeany means and/or methods for interacting with the portable infusiondevice 110, or any device associated with the portable infusion device110, through direct manipulation or commands.

One possible advantage of some portable infusion device 110 embodimentsmay be the ability to provide a user with generally improved usability.This has been achieved by integrating a user-centered GUI 454 designthat may provide an interface having at least one display screenrepresentation or page 456 that reduces user-error and enhances theefficiency and user satisfaction of the device 110. It may be a benefitfor some embodiments to offer generally complex programs in a portableinfusion device 110 for assisting in the delivery of insulin that bestserve the user's insulin needs. As discussed above, in order to optimizethe delivery of insulin to best serve the user's insulin needs, a numberof factors must be taken into account for determining the user's presentand predicted future insulin needs. Therefore, the GUI 454 of theportable infusion device 110 may provide a user with enhanced usabilityfor interacting with the device 110 in order to customize deliveries ofinsulin that best meet the insulin needs of the user.

Some embodiments of the portable infusion device 110 may also includemultiple other capabilities in addition to delivering one or moremedicaments (i.e., insulin). For example, the portable infusion devicemay be capable of interacting with a personal computer (PC) foruploading and downloading data, various file types (e.g., JPEG, PDF) andprograms. The portable infusion device 110 may also access and sendinformation wirelessly to a PC or other electronic device (e.g.,printer, memory storage device). These functions, for example, may beparticularly beneficial to a user for sending and receiving informationto a physician, or uploading new or upgrading current programs onto theportable infusion device 110. Furthermore, the portable infusion device110 may have instructions, or accessible by the user and/or processor170 for converting information on the device 110 into various fileformats, e.g., portable document format (PDF), word processingdocuments, JPEG, etc., which may be distributed and shared among variouselectronic devices. The GUI 454 of the portable infusion device assistsin improving the usability of at least these capabilities. In addition,some GUI 454 embodiments may be available to a user by downloading asoftware application onto the user's cell phone and/or PDA, which wouldallow the user to use their cell phone or PDA as a remote commander tothe portable infusion device 110.

Some GUI 454 embodiments discussed herein, including the GUI 454 shownin FIG. 9A, may use a generally intuitive interface for an improved userexperience of a portable infusion device 110. A user interacting withsome embodiments of the GUI 454 may experience improved usability overpast and current infusion devices. Therefore, some embodiments of theGUI 454 may offer an improved user efficiency, user satisfaction, andreduction in user error when operating the portable infusion device 110.In addition, a user interacting with the GUI 454 of the portableinfusion device may find learning to use the device to be generallysimple due, at least in part, to a generally intuitive interface suchthat operating the device 110 may be intuitive and/or learned by simplyobserving the device 110.

With improved usability, a user may be enticed to interact with theportable infusion device 110 in order to use the device to a greaterdegree than what is typically experienced with past and present infusiondevices. In some cases, there is a need for portable infusion deviceswith improved usability so that users do not simply “set-it-andforget-it,” as what is often done with other infusion devices becauseusers may find them too difficult, time consuming, and/or confusing tooperate. When a user “sets-it and forgets-it,” the user of the infusiondevise relies on a small number of generally generic delivery profilesthat do not fully represent the user's present and future insulin needs.Therefore, some of the GUI 454 embodiments discussed herein may at leastimprove upon some of the past and present deficiencies of infusiondevices by providing a portable infusion device with improved userfriendliness.

In addition, some of the GUI 454 embodiments discussed herein may atleast improve a physician and/or clinician's ability to respond to apatient's needs. For example, a user of the portable infusion device mayinform a physician of a problem the user has been experiencing, e.g.,chronic fatigue, mood swings, large swings in BG levels, etc. Thephysician may then analyze any of the delivery profiles 458 programmedin the user's device 110 to determine which of the settings to modify inorder to try and improve the user's wellbeing. For instance, by viewingthe delivery profiles 458, the physician may be able to determine thatone of the delivery profile settings is programmed too low, which mayhave been contributing to not enough insulin being delivered to theuser. Therefore, the physician may then directly modify the setting,e.g., increase the setting value, that was determined to be programmedtoo low. As will be discussed in more detail below, some embodiments ofthe GUI 454 enable a user, or the user's physician, to view multiplesettings across multiple time spans within at least one delivery profile458, which may be displayed on a single touch screen 452 display 450 (asshown by way of example in FIG. 49). Furthermore, from this condensedview of information, a user or physician may directly manipulate one ormore of the settings displayed on the touch screen 452 display 450. Thiscondensed view, and the added benefit of enabling direct manipulation ofthe settings displayed in the condensed view, may further improve aphysician's ability to respond efficiently and effectively to apatient's needs.

At least a part of the GUI 454 includes an information architecture 460and a hierarchy of pages (or display representations) 456 that assistthe portable infusion device 110 in interacting with the user bycollecting and displaying information, as well as guide a user on how touse the device 110. The information architecture 460 may provide ageneral roadmap for accessing a variety of programs and informationaccessible by the control unit, or processor 170, of the portableinfusion device 110. A user is generally able to interact with the GUI454 to set up, for example, customizable insulin delivery profiles 458based on the user's current and predicted future insulin needs. This maybe accomplished, at least in part, by a user navigating through one ormore infusion workflows, or protocols embedded within a programaccessible by the processor 170 of the portable infusion device 110.

An infusion workflow 464, or protocol, may be at least part of a programthat, when executed by the processor, assists a user to at least programor control the portable infusion device 110 and/or at least oneoperation comprising enter, change, confirm, or view various informationwithin the device 110. Any part of a workflow 464 or protocol mayinclude any number of queries for prompting the user to enter, modify,or confirm information, which are typically presented to the user on thedisplay.

For example, a program accessible by the processor that includes aninfusion workflow 464 or protocol may enable a user to program theportable infusion device to deliver insulin to the user. In addition, aninfusion workflow 464, or protocol, may present the user with a numberof understandable queries for allowing the user to enter, confirm ormodify information regarding the physiological conditions of the user.For instance, queries presented to a user during the execution of aprogram may enable a user to set various settings within the portableinfusion device (e.g., the time, date, or one or more alarms) and/orenter information about a users present or predicted conditions (e.g.,blood glucose level, physiological conditions, food to be ingested,etc).

In some embodiments, the linear approach of a workflow 464, or protocol,for programming the portable infusion device is at least limited. As analternative approach, the user is instead provided with a virtual form462 displayed on the touch screen 452 display 450 for the user tocomplete. A virtual form 462 enables a user to directly select andmanipulate one or more parts of a displayed virtual form 462, with eachpart generally representing a setting. In this way, a user is notrequired to navigate through a generally linear workflow 464 or protocoland/or prompted with a series of queries. Instead, the user is presentedwith generally a single page 456 where the user completes the virtualform 462 in order to initiate a programmed delivery of insulin, as willbe discussed in greater detail below and shown by way of example inFIGS. 53A-53C and 48-49.

Some GUI page 456 or screen representation embodiments of the GUI pagehierarchy enable a user to easily access and view one or more settingsand information within the portable infusion device. A single page 456may include one or more objects 466 simultaneously presented on thetouch screen 452, where an object 466 may be any number of text,numbers, graphs, pictures, video, or combination thereof which displayunderstandable information to a user. The information may have beenentered by a user and/or presented by the portable infusion device 110,and may at least be one of information regarding the amount of insulinalready present in the body, e.g., insulin on board; blood glucoselevel; trending glucose level; insulin sensitivity/insensitivity;glycemic index; metabolism; metabolic rate; stress level; physiologicalconditions, e.g., age, health, sickness, diurnal cycles, etc; measurableparameters: hormones, steroids, etc.; pharmacokinetics of themedicament, e.g., age of insulin, decay rate, etc.; food to be ingested,e.g., carbohydrates, proteins, fat; activity; use history; calendaredevents; environment, e.g., temperature, humidity, pressure, etc.; andthe like. An object 466 may represent any number of information withoutdeparting from the scope herein, and may also be in the form of apictogram to generally intuitively represent, for example, a program,file, user, setting, status, profile, action or other entity discussedherein.

Furthermore, any object 466 may be a soft key so that when the usertouches the object soft key, the “selection” of the object 466 iscommunicated to the processor. How the processor 170 interprets theselection of an object 466 depends, at least in part, on which programis currently executing and what the selected object 466 represents. Forinstance, selection of an object 466 may be processed by the processor170 such that the user is given an opportunity to modify displayedinformation, or the user may be directed to another page 456 within theGUI page hierarchy. Various examples of programs, workflows 464,displayed objects 466, and user selections of objects 466 displayed onthe portable infusion device 110 display 450 will be described in moredetail below.

By way of one example, an object 466 displayed on the touch screen 452may represent the number of units of insulin programmed to be deliveredto the user. In addition, this object 466 may be a soft key so that whenthe user selects the object 466, the user is given the opportunity tomodify the number of units of insulin programmed to be delivered to theuser. The number may be modified by a variety of operations. Forexample, the display may show a virtual keyboard or keypad 500 foractuation, or may receive input through multi-touch techniques, or mayreceive input through actuation of a physical button or keypad (notshown). One possible advantage of some embodiments may be that multipleobjects 466 may be simultaneously displayed on the touch screen 452 ofthe portable infusion device 110, including any one of which may be asoft key, so that any one of the multiple modifiable objects 466simultaneously displayed may be directly manipulated by a user.Moreover, the user can view values of multiple parameters, such asparameters comprising a delivery profile 458, on a single display screen450 or page 456. Therefore, a user is not limited to having to scrollthrough more than one page 456 to view, enter, or change, for example, avalue, range, graph, or any object 466 representing any number ofinformation entered by the user or presented by the portable infusiondevice 110.

GUI 454 embodiments of the portable infusion device may serve multiplepurposes, including informing the user about various settings,activities, and/or statuses relating to the device, as well as providinga means for the user to enter, confirm, and/or modify displayed settingsand/or values. Furthermore, the GUI 454 may also provide the user withvideo or animated graphics to enhance the ability to instruct or informa user and improve usability. For example, animated graphics and/orvideo may be displayed on the touch screen 452 to assist in instructingthe user on how to operate the portable infusion device 110, such asload insulin into the device 100.

The GUI 454 of the portable infusion device 110 may also include anynumber of features for assisting in preventing the user from entering,changing, or accepting any information that may be incorrect. Forexample, the user may be presented with confirmation pages and/orqueries where the user is required to confirm one or more presentedinformation. Some GUI embodiments of the portable infusion device mayalso prevent the user from selecting one or more objects 466 displayedon the touch screen 452 in order to prevent the user from selecting orentering incorrect information, as will be discussed in more detailbelow. Some GUI embodiments of the portable infusion device may preventunauthorized access to accommodate at least privacy, HIPPA regulations,and/or other concerns. For example, passwords, biometric sensors, etc.,could be incorporated in the portable infusion device system as well asencrypted processors and data transmission to assist in added securityand/or privacy of the device.

GUI 454 embodiments may also interact with a variety of pre-programmedor user programmed alarms integrated in the portable infusion device 110for at least assisting in alerting the user and/or preventing usererror. For instance, the portable infusion device may utilize the GUI454 to present important information to the user as to the status of thedevice (e.g., battery life, remaining medicament in the cartridge,occlusion in the fluid line, etc). For example, the portable infusiondevice 110 may warn the user by changing one or more colors on thedisplay screen 450 of the portable infusion device 110 to alert theuser. Alternatively, or in combination, the portable infusion device 110may alert the user by sounding an alarm (e.g., a beeping noise) orvibrating the device. The user may program the portable infusion device110 to alert the user for various reasons relating to at least one of aphysiological measurement and/or a portable infusion device status. Forexample, in the context of insulin delivery, a user may program theportable infusion device to alert the user when a predetermined amountof insulin, e.g., one hundred units, fifty units, twenty-five units, orany number of units of insulin remain in the portable infusion devicefor dispensing.

Turning now to the figures, FIG. 26 illustrates one embodiment of aninformation architecture 460, which illustrates at least a part of theGUI page 456 hierarchy, the interconnectedness of information within thedevice 110, and programmable settings of the portable infusion device110 accessible by a user. Generally, in FIG. 26, the display screen 450of each page 456 at a level of the hierarchy includes display objects466 representing all of the objects 466 in the hierarchy levelimmediately below so that selecting one page will produce a screen orpage 456 display with objects 466 that will allow navigation to the nextlower level. In general, each display 450 will also include at least oneobject 466 for selection to return to the previous level in thehierarchy, and/or a physical “back” button may provide the samefunctionality. The information architecture 460 illustrated in FIG. 26,although shown in a configuration suitable for delivery of medicamentsuch as insulin, is not meant to be exhaustive, and is, instead, a broadexemplary representation of some of the information and settings of theportable infusion device 110 accessible by a user. In addition, andshown surrounded in dashed-lines at the bottom of FIG. 26, the portableinfusion device may include a number of various GUI features andfunctions 470, e.g., graphs, indicators, alerts, etc., which may begenerally embedded and accessible by a user within the informationarchitecture 460.

The “home” 472 location of the FIG. 26 information architecture 460 mayrepresent a home screen page 474 on the display screen 450, as shown byway of example in FIG. 27. The home location 472 of the informationarchitecture 460, or the home screen page 474, generally serves as thestarting point for a user to access any information, program, or settingembedded within the information architecture 460, or GUI page 456hierarchy. The home screen 474 is typically the screen representative orpage 456 that is displayed to the user upon applying power or switchingon the device 110. Any information displayed in the informationarchitecture 460 may be displayed in at least part of a page 456 withinthe GUI page 456 hierarchy.

FIG. 27 illustrates one embodiment of a home screen page 474 displayingvarious objects 466, including a time object 476 (displaying the timeand date), options object 478 (a menu option), a status indicator object480 (displaying device status information, e.g., battery life), bolusdelivery object 482 (initiates a bolus delivery program), blood glucose(BG) object 484 (directs user to deliver insulin based on BG level),insulin on board (IOB) object 486 (displays how much insulin remains inuser's body over a period of time due to the delivery of one or moreboluses), and a delivery profile object 488 (displays variousinformation regarding insulin delivered to user). Any one of thedisplayed objects 466 on the home screen page 474 may be a soft key sothat when a user selects any one of the objects 466, such as by touchingthe object with a finger or stylus, the processor 170 receives theselection and performs operations that execute instructions and/orreceive further input, so the user is able to at least do one or more ofthe following; modify the object 466, be directed to a new page 456, orinitiate a workflow 464 or protocol of a program. GUI 454 embodimentsmay provide a user with the ability to view and/or select multipleobjects 466 simultaneously displayed on the touch screen 452 display 450of the portable infusion device 110. In contrast, a user of an infusiondevice 110 without the capability of simultaneously displaying multipleselectable objects 466 would have to maneuver though multiple displayscreen representations 456 to accomplish what is readily available on asingle page 456 of the present GUI page 456 hierarchy.

FIG. 28 illustrates an embodiment of a bolus object 482, which may bedisplayed on at least the home screen page 474. The bolus object 482 maybe a soft key so that when selected by the user the processor initiatesexecution of a bolus delivery program that allows a user to setup abolus delivery of insulin. Furthermore, the bolus delivery program mayinclude a bolus workflow 490 or protocol which may, in combination withthe processor 170 and memory 172 of the portable infusion device 110,present the user with pages 456 or screen representations having anumber of queries and information for setting up an appropriate bolus ofinsulin to be delivered to the user.

In addition, once a bolus delivery has been setup, a bolus object 482may also include a bolus status indicator 492 that provides feedback tothe user regarding the programmed bolus delivery of insulin. Forexample, the status indicator 492 may provide feedback as to how much ofthe bolus has been delivered to the user. The bolus status indicator 492may display the total bolus volume of insulin to be delivered (shown byway of example as 0.7 units). The bolus status indicator may alsoprovide animated feedback, such as an animated indicator line 494 or barthat moves in a generally intuitive manner such that the status of thebolus delivery is generally understood by the user. Furthermore,feedback may be provided to a user for any number of reasons and may beportrayed to a user in various configurations, e.g., one or moreblinking lights, color changes on the display 450, etc.

For example, the animated indicator line 494 may travel from one side tothe other of the bolus status indicator 492 as the bolus is delivered tothe user. By way of further example, as the animated indicator line 494moves, the color on one side of the animated indicator line 494 may be adifferent color than the other side such that it is generally intuitiveto a user as to the status of the bolus delivery. Therefore, the bolusstatus indicator 492 may provide efficient and user-friendly informationthat is easily accessible for a user to view and understand the statusof a insulin being delivered.

FIG. 29 illustrates one embodiment of a bolus workflow 490 comprised ofa number of interrelated pages 456 and pages displaying queries forenabling the user to program the portable infusion device 110 to deliveran appropriate bolus of insulin. The bolus workflow 490 may be initiatedfrom the home screen page 474 in response to the user selecting thebolus object 482 soft key on the touch screen 452. Once the user selectsthe bolus object soft key 482, the processor 170 may load a bolusdelivery program that provides instructions to the processor 170 forguiding a user through the bolus workflow 490. For instance, once theprocessor 170 is executing the bolus delivery program, the program willpresent the user with a page such as the insulin entry page 496 asillustrated in FIG. 31, that provides the user with a first query 498 ofthe bolus workflow 490. The first query 498 of the bolus workflow 490may ask the user to either enter the approximate amount of carbohydrates(e.g., in grams) the user predicts to consume, or the volume of insulin(e.g., in units) the user would like delivered as shown in FIG. 31.

A user may enter the amount of carbs or volume of insulin in order toassist in programming the portable infusion device to deliver generallyan appropriate bolus of insulin based on the amount of food the user haspredicted to consume, which may also be referred to as the food or mealbolus. If the device 110 is programmed for the user to enter the numberof carbs, the processor 170 may use a carb ratio (the amount of insulindelivered for every X number of carbohydrates consumed) to determine thefood bolus of insulin to deliver to the user. In addition, a user mayprogram the device 110 to prompt the user to enter any one or more of avariety of information to determine an appropriate food bolus, which maygenerally depend on the type of information the user wants to enter. Forexample, the user may program the device 110 to prompt the user to entera blood glucose level and the number of carbs predicted to be consumedfor programming a food bolus. Therefore, the portable infusion device110 enables a user to customize the device 110 regarding what type ofinformation the user will be prompted to enter for programming at leasta bolus of insulin.

FIG. 31 illustrates one embodiment of a virtual keypad 500 which may bedisplayed on the touch screen 452 for allowing a user to inputinformation. A virtual keypad 500 may include one or moreuser-interactive virtual keys 502 that enable a user to select one ormore of the virtual keys 502 to enter information associated with eachvirtual key 502. A virtual keypad 500 may be presented to a user on thedisplay 450 anytime the user selects to enter or modify, or is requestedto enter or modify, any one of the multiple settings and/or entriesstored on the portable infusion device 110. One or more virtual keys 502illustrated in FIG. 31 are shown as relating generally to variousnumbers and a decimal.

Additionally, and shown by way of example in FIG. 35, a virtual keypador keyboard 500 may include one or more virtual keys 502 relating to oneor more letters and/or numbers. A virtual key 502 relating to one ormore various input, e.g., number, letter, symbol, etc., as shown in someof the virtual keys 502 in FIG. 35, a may perform various interactionswith these virtual keys 502 to cause a particular input to be made. Forexample, a user may sequentially tap, or select, a virtual key 502 oneor more times to cause various entries to be made. By way of furtherexample, a user may touch a virtual key 502 one time to input the letter“a,” or may touch the same virtual key 502 two times to input the letter“b.” Any number of user interactions with virtual keys 502 to causevarious types and forms of input may be used to at least improveusability of the portable infusion device 110.

For instance, a virtual keypad 500 may be presented with queries in thetext entry field 504 (such as the “enter insulin” query presented in thetest field in FIG. 31) which may allow a user intuitively to respond tothe query by selecting one or more of the virtual keys 502. As the userselects a virtual key 502, the information associated with the selectedvirtual key 502 is displayed in the text entry field 504. This providesthe user with the ability to view the information selected and decide todelete or enter the selected information. Therefore, the virtual keypad500 offers a user an efficient and intuitive means for enteringinformation.

Although the virtual keypad 500 illustrated in FIG. 31 shows an “enterinsulin” query in the text entry field 504, any number of text may bedisplayed in the text entry field 504 for either prompting or requestinginformation from a user. Furthermore, the virtual keys 502 may displayand relate to any one of several types of user input, e.g., letters,numbers, symbols, text, pictograms, etc. for allowing a user to enter avariety of information into the portable infusion device 110.Additionally, an enter object 506, a delete object 508, and one or morenavigation objects 510 (e.g., back, skip, next) may be presented as partof, or in combination with, the virtual keypad 468 for allowing a userto navigate to another page. Navigation objects 510, e.g., back, skip,and next, assist in enabling the user to easily navigate through aseries of interconnected pages 456, such as in the bolus deliveryworkflow 490, and may be presented on any page within the GUI page 456hierarchy.

As illustrated in FIG. 29, once the user either skips or enters aselected entry in response to the first query 498 of the bolus workflow490, the user is presented with a second query 512. The second query 512asks the user if the user would like to enter a blood glucose level intothe system. If the user chooses not to enter a blood glucose level, theuser is directed to a bolus confirmation page 514, as shown in FIG. 30.If the user chooses to enter a blood glucose level, the user is directedto a third query 516 where the user is asked to enter a blood glucoselevel. A user would then enter a blood glucose level that the user, forexample, obtained from a blood glucose measuring tool. As discussedabove, the user may be presented with a virtual keypad 468 for enteringa blood glucose level.

Alternatively, the portable infusion device 110 may include a featurethat either continuously or selectively reads the user's blood glucoselevel directly. If the portable infusion device 110 includes such afeature, the user would not have to enter a blood glucose level andwould not be presented with the third query 516. Instead, the bloodglucose monitoring feature would input the user's blood glucose levelautomatically into a workflow or protocol, as necessary, or simplyrequire the user to confirm a blood glucose level gathered from theblood glucose monitoring feature.

The fourth query 518 of the bolus workflow, may ask the user whether theuser would like a correction bolus. A correction bolus may be used todeliver additional insulin in order to reach the user's programmedtarget BG level (the BG level the user would generally optimally like tohave). If the user chooses not to have a correction bolus, the user isdirected to a bolus confirmation page 514, as shown in FIG. 30. If theuser chooses to have a correction bolus, the user is directed to a fifthquery 520 asking the user to enter an appropriate correction bolus, orconfirm a stored correction bolus.

Once the user has either skipped or entered information for at least oneof the first five queries 498, 512, 516, 518, 520 of the bolus workflow490, the user is presented with a bolus confirmation page 514. FIG. 30illustrates one embodiment of a bolus confirmation page displaying astandard bolus object 522, extended bolus object 524, status indicatorobject 480, cal/enter insulin object 526, correction bolus object 528,IOB object 486, and total units object 530—any one of which displayinformation either entered or confirmed by the user, or processed by theprocessor 170 based on any one of an entered, sensed, stored orconfirmed information. More specifically, the standard bolus andextended bolus object 522 and 524 may be selected by a user forinitiating a standard or extended bolus delivery of insulin,respectively. The status indicator object 480 may provide information tothe user regarding the status of the portable infusion device 110, whichwill be discussed in greater detail below. The cal/enter insulin object526 may display the amount of insulin calculated based on the expectedconsumption of carbohydrates or the number of units of insulin to bedelivered entered by the user. The IOB object 486 may displayinformation to a user regarding the amount of insulin that has beendelivered to the user in the form of a bolus, and the general amount oftime the user's body will need in order to metabolize that insulin.

One benefit of embodiments discussed herein may be that any one of theobjects presented on the bolus confirmation page 514 may be a soft keyfor allowing a user to modify any one of the objects as well as decidewhether a standard or extended bolus is the appropriate deliveryprofile. For example, the total units object 530 displayed on the bolusconfirmation page 514 may be a soft key so that when a user touches, orselects, the total units object 530, the user is then able to modify thetotal units of insulin programmed to be delivered.

By way of further example, if the user touches the total units object530, the user may be directed to a new page 456 displaying a virtualkeypad 500 to enable a user to enter an appropriate number. Once theuser enters an appropriate number, the user would then be directed backto the bolus confirmation page 514. Alternatively, the user may not bedirected away from the bolus confirmation page 514 to modify an object.For example, a user may touch either the total units object 530 on thebolus confirmation page 514 and be given a visual or audible indicator(e.g., flashing total units object, a color change of the total unitsobject, and/or an audible indicator) to inform the user that the totalunits of insulin may be altered. The user may then touch the “plus”object 532 or “minus” object 534 (as shown in FIG. 30) to cause thetotal units of insulin to incrementally increase or decrease,respectively. A plus object 532 and minus object 534 may be displayed onany page 456 necessary, and may be displayed instead of, or incombination with, a virtual keypad 500 for entering information. Oneadvantage of the virtual keypad 500 is that the user may enter a valuefor a setting with greater resolution in comparison to selecting “plus”and “minus” objects 532 and 534 on the touch screen 452 display 450 thatare set to increase or decrease, respectively, at generally specificincrements.

By way of another example, a user may select the edit object 536 softkey on the bolus confirmation page 514 which allows the user to alterone or more subsequently touched objects 466 displayed on the bolusconfirmation page 514. An edit object 536 soft key may be displayed onany page 456 in the GUI page hierarchy for modifying one or moremodifiable objects 466, as described above. Furthermore, any modifiableobject displayed on the touch screen 452 display 450 of the portableinfusion device 110 may be selected and modified by a user using anymethod and/or means described herein.

As discussed above, the bolus confirmation page 514 displays more thanone modifiable object generally related to the programmed delivery of abolus of insulin to a user. One possible advantage of some GUIembodiments of the portable infusion pump may be the ability to view anddirectly modify more than one modifiable object displayed on the touchscreen 452. Because GUI 454 embodiments may be able to display multiplesettings that may be directly manipulated by the user, the user is notrequired to memorize stored entries and navigate through multiple pages456 to at least view or modify a setting. The ability of the GUI 454 ofthe portable infusion device 110 to provide this feature may improve theusability of the device and reduce user error.

In addition, the bolus confirmation page 514 also offers the user theoption to select a standard or extended bolus by touching either thestandard bolus object 522 or extended bolus object 524, respectively. Asillustrated in the bolus workflow 490 example FIG. 29, a sixth query 538is generally presented on the bolus confirmation page, which asks theuser to choose between a standard or extended bolus of insulin.Generally, a standard bolus delivers the programmed volume of insulinimmediately upon completion of the bolus delivery set-up, and anextended bolus allows a user to program the portable infusion device todeliver the bolus over a defined duration.

If the user chooses a standard bolus (e.g., by selecting the standardbolus object 522 followed by the deliver object 540), the user may thenbe presented with a bolus delivery confirmation page where the totalunits of insulin to be delivered to the user is displayed along with acountdown timer 542 and a cancel object. The countdown timer 542 maybegin at any time duration, either set by the user or pre-programmed inthe portable infusion device 110, to allow the user some time to cancelthe delivery of the bolus, e.g., by selecting the cancel object. Thecountdown timer appears on the display 450 and begins to countdown tozero at about the same time the bolus delivery confirmation page appearson the touch screen 452. By way of further example, the countdown timer542 may begin at five seconds, thus giving the user about five secondsto decide whether to select the cancel object to cancel the programmedbolus delivery of insulin.

Once the countdown timer 542 counts down to zero time, the processor 170instructs the delivery mechanism 384 or 132 of the portable infusiondevice 110 to deliver the programmed bolus of insulin to the user. If anemergency exists, for example, and the user wants to attempt to stop theinsulin being delivered to the user after the countdown timer reacheszero, the user may hard-stop the portable infusion device by poweringoff the device. The countdown timer 542, along with the displayed totalvolume of insulin to be delivered and a cancel object 544, may provide auser with a further opportunity, in addition to the bolus confirmationpage, to generally ensure a proper amount of insulin is being deliveredto the user. A countdown timer 542, along with a cancel object 544, maybe displayed to a user on the touch screen 452 display 450 prior to anydelivery of insulin to a user and is not limited to only prior to thedelivery of a standard bolus. It may be a benefit of some embodiments toprovide the user with multiple opportunities to view and modify insulindelivery settings in order to at least improve the usability and reduceuser error of the portable infusion device 110.

Alternatively, to the standard bolus, the user may choose to have anextended bolus delivered (e.g., by sequentially selecting the extendedbolus object 524 followed by the deliver object 540 on the bolusconfirmation page 514). The user may then be directed to an extendedbolus setup page 546 where the user is presented with multiplemodifiable objects representing settings relating to the delivery of anextended bolus. FIG. 32 illustrates one example of an extended bolussetup page 546, including a total units object 530 (displaying the totalunits of insulin to be delivered), duration object 548 (displaying theduration that an extended bolus will be delivered), insulin now object550 (displaying the units of insulin to be delivered generallyimmediately after setup of the extended bolus), and an insulin extendedobject 552 (displaying the units of insulin to be delivered over thedefined duration)—any one of which may be a soft key, so that whenselected a user can modify the selected object. Any one of themodifiable objects may be modified by at least any one of the methodsdescribed herein for modifying an object, e.g., selectinguser-interactive plus and minus objects 532 and 534 to increase ordecrease, respectively, object 466 values; direct user entry by way ofselecting one or more of a letter, number, or symbol displayed on thetouch screen 452 display 450 in the form of a virtual keypad 500; oruser selection of an edit object 536 whereby subsequent objectselections allows the user to modify the objects 466.

A user who decides to have an extended bolus of insulin delivered maydefine a number of units to be delivered immediately upon completion ofthe extended bolus delivery setup, as well as a defined number of unitsdelivered over a defined duration. This customizable delivery profilemay benefit the user by delivering insulin generally more equivalent tothe user's insulin needs over a period of time, which may be due to anyone of the various factors influencing a body's insulin needs, asdescribed above.

One advantage of a portable infusion pump 110 for medicament delivery ingeneral and specifically in the context of insulin is the ability todeliver such complex and customizable insulin delivery profiles 458 to auser that would be extraordinarily difficult, if not impossible, toachieve with standard syringe delivery methods currently used by asignificant number of diabetics. As the complexity and customization ofinsulin delivery devices increase in order to provide users withimproved delivery profiles, so may the user errors. Again, it may be abenefit of some embodiments to provide a GUI 454 with improvedusability, which include the ability to simultaneously present multiplemodifiable settings for a user to either view or modify. Therefore, thismay allow embodiments of the portable infusion device 110 to provide theuser with complex insulin delivery profiles 458 that generally betterserve the user's insulin needs, while also reducing user error byproviding the user with condensed and easily modifiable informationpertinent to the delivery profiles 458.

Similar to the standard bolus setup described in the example above, oncea user has completed viewing and modifying any information presented onthe extended bolus setup page 546, the user may select the deliverobject 540 to initiate the delivery of the extended bolus. Asillustrated in FIG. 33, the user may then be presented with an extendedbolus delivery confirmation page 556 where information pertinent to theprogrammed extended bolus is displayed (e.g., total units of insulin,units of insulin to be delivered generally immediately after deliverysetup, units of insulin to be delivered over an extended duration, theduration over which the extended bolus will be delivered, etc.). Inaddition, a confirm object 558 and cancel object 544 are displayed toallow a user to either confirm or cancel the extended bolus programmedin the portable infusion device for delivery. The user may select theconfirm object 558 to initiate delivery, at which time a countdown timer542 appears on the touch screen 452 (as shown in FIG. 33) and gives theuser another opportunity to select the cancel object 544 to cancel theprogrammed delivery of insulin, as described above. Once the countdowntimer 542 counts down to zero, the processor 170 instructs the deliverymechanism of the portable infusion device 110 to deliver the programmedextended bolus of insulin to the user.

Another feature of the portable infusion device 110 for assisting inpreventing an undesired volume of insulin delivered to a user isreferred to herein as the dynamic error prevention feature 560. Thedynamic error prevention feature 560 of embodiments may assist inpreventing a user from incorrectly selecting one or more objects 466displayed on the touch screen 452 display 450. For example, andillustrated in the insulin delivery example of FIG. 34, a virtualnumeric keypad 500 may be displayed on a display screen 450 whichinclude number and symbol object soft keys (displayed as virtual keys502) for user selection. However, any one of the virtual keys 502 may bedeactivated such that when a user touches the deactivated object 562, itis generally not communicated to the processor 170 as an entry. At leastone object appearing on the display 450 will be a soft key so that whenselected, the processor 170 will be informed of the selection forsubsequent processing. The deactivated objects 562 may ensure that auser does not accidently enter in a value that is too large or too smallbased on information known by the portable infusion device 110, forexample, either as pre-programmed or user defined limits. Thede-activation and activation of objects 466 presented on the touchscreen 452 for user selection is dynamic and may change subsequent oneor more selections by a user on the touch screen 452.

For instance, in the context of insulin delivery, the user may haveprogrammed the portable infusion device 110 to limit the allowablevolume of insulin to be delivered over a specified duration. Therefore,if the user programmed the portable infusion device 110 not to allowmore than twenty-five units of insulin to be delivered over the periodof an hour, the virtual keyboard 500 would not allow the user toinitially select any of the virtual keys 502 corresponding to a valuegreater than two. If the user selected a virtual key 502 displaying aone or a two, the number would appear, for example, in the text field504 on the display 450. However, if the user attempted to select anobject 466 displaying a number three, or greater than three, either nonumber would appear in the test field 504 and/or a warning may bedisplayed on the display 450 for informing the user that the selectionis not acceptable. Because this feature is dynamic, after the userselects an acceptable entry, the deactivated and activated objects maychange. Therefore, if the user selects an object 466 displaying a one ora two, as described above, any object 466 displaying a number less thanor equal to five would be activated for user selection while any object466 displaying a number greater than five would be deactivated.Therefore the user would be prevented from entering a value greater thantwenty-five, as previously defined by the user. Furthermore, after theuser selects a second acceptable entry, at least all of the numericvirtual keys 502 would be deactivated such that the user would only beable to select the delete 508, enter 506, back 510 or skip 510 objectsin order to prevent the user from selecting an entry greater thantwenty-five. Therefore, the dynamic error prevention feature 560 assistsin preventing the user from entering an undesired value, and may be usedto generally limit a user's available selections on the touch screen 452display 450. In addition, the dynamic error prevention feature 560advantageously assists in relieving the user from having to read anerror message and then go back and re-enter a new setting value. Thismay benefit the user by eliminating time wasted due to entering valuesthat are programmed to be unacceptable.

The dynamic error prevention feature 560 may also improve usability byrelieving the user from having to recall what had been previouslydetermined to be appropriate limits of various settings, for example,while being consulted by a physician. Therefore, a physician,physician's assistant, nurse, certified diabetes educator, etc., mayassist a user of the portable infusion device to store acceptableparameters to any number of settings modifiable by a user so that a userdoes not later attempt to program a user modifiable setting that is outof the user's appropriate range.

In addition, some GUI 454 embodiments may display the activated anddeactivated objects such that they are visually distinct from each otherto a user viewing the display. For example, the deactivated objects 562may appear darker in color and/or less illuminated than the objectsacceptable for selection. The visual distinction may assist inpreventing a user from wasting time attempting to select objects thatare deactivated and unable to select this may improve the efficiency anduser satisfaction of the portable infusion device 110.

FIG. 34 illustrates an example of the dynamic error prevention feature560 in the context of insulin delivery by showing a virtual keypad 500displayed on the touch screen display. The virtual keys 502 displaying adecimal and numbers less than two and greater than six are displayeddarkened relative to other objects (shown schematically in FIG. 34 ashash marks) in order to visually indicate to a user that those objectsare unacceptable for selection. Objects displaying numbers two throughsix are displayed in higher relative contrast or in different colors,brightness levels, or combinations thereof, in order to visuallyindicate to a user that those objects are acceptable for selection. Anynumber of visual or audible indicators may be used to assist in makingobjects acceptable for selection distinct from objects not acceptablefor selection without departing from the scope herein.

FIGS. 36-38 illustrate additional embodiments of the home screen page564, 566 and 568 that may be displayed on the touch screen display ofthe portable infusion device in the context of insulin delivery. A usermay select among various configurations and/or displayed information tohave as the user's home screen page, which may be continually changed asdesired or necessary. For instance, the user may select from a varietyof delivery profile objects 488 that may be displayed, for example, inthe bottom portion of the display screen 450, such as the pump statusobject shown in FIG. 36. The ability for a user to generally customizethe information presented on the home screen page generally improves theusability of the portable infusion device.

A delivery profile object 488 may display one or more items ofinformation relating to the history, current status, and/or programmedfuture status of the delivery of insulin from the portable infusiondevice 110. In addition, the one or more items of information displayedwithin a delivery profile object 488 may be presented in numerical,textual, graphical and/or symbolic form. Additionally, as describedabove, where at least a part of the display 450 is configured forgraphical representation 570, the graphic representation 570 may beconfigured for manipulation by a user touching or otherwise “clicking”the representation 570 and dragging the representation 570 in apredefined manner so as to change the form, e.g., height, width, shape,etc. of the representation.

A delivery profile object 488 may display information relating to thestatus of the pump, where the user is informed that all deliveries havebeen stopped, or what name or type of delivery profile 458, or personalprofile, is currently being delivered to the user. As illustrated by wayof example for insulin delivery in FIG. 37, the delivery profile object488 (shown labeled as “IOB”) may display information relating to theamount of insulin that has, and will be, in the user's body as a resultof one or more boluses of insulin delivered to the user over a givenamount of time. Furthermore, the IOB information may be displayed innumerical, textual, graphical and/or symbolic form. FIG. 38 illustratesan example in the context of insulin delivery of the user's IOBinformation displayed in graphical form 570 in the delivery profileobject. By presenting this information in graphical form 570, a user mayat least easily visualize the decay rate of insulin remaining in theuser's body over a generally defined duration of time (based on thepersonal and/or delivery profiles of insulin programmed to be deliveredto a user over the defined duration of time).

In general, a user may select among different home screen pagerepresentations and configurations for displaying various information ina variety of forms, e.g., graphical, numerical, textual, symbolical.This feature enables the user to customize the home screen page 474,564, 566, 568 so that it generally displays information that is ofparticular interest to the user. Additionally, it allows the user somefreedom to select what information the user would like to view incombination on the display screen 450. As discussed above, it may be abenefit of some embodiments to provide the user with the ability to viewmultiple selectable and/or modifiable objects 466 simultaneouslydisplayed on the display screen 450 for comparing and directlymanipulating one or more of the displayed information. A user may accessa setup screen or initiate an administrative process that provides theuser with options 572 for setup, as indicated in the hierarchy of FIG.26.

FIG. 39 illustrates an embodiment of a home screen page 574 furtherillustrating an embodiment of a device status indicator 480. A devicestatus indicator 480 for insulin delivery that may be advantageouslyconfigured such that it is compact enough to be displayed on most pages456 of the GUI 454 page 456 hierarchy and provide generally more vitalinformation regarding the status of the device 110. For example, and asshown in FIGS. 39 and 40, a device status indicator 480 may displayinformation regarding device 110 conditions, such as the amount ofinsulin and battery power remaining in the portable infusion device. Adevice status indicator may display any variation of numbers, text,and/or symbols for indicating to a user the status of various deviceconditions. Additionally, a device status indicator 480 may show one ormore indicator bars 576 that may, for example, light up and/or changecolor to indicate to a user the condition of each status.

For instance, when the portable infusion device 110 is generally fullycharged, all four of the indicator bars 576 may be a particular colorand/or illuminated such that it is generally intuitive to a user thatthe portable infusion device 110 is fully charged. As the portableinfusion device 110 consumes power, one or more indicator bars 576 maychange in appearance, such as its color, brightness, or it may no longerilluminate. This change in appearance allows the user intuitively tounderstand that the portable infusion pump is no longer fully charged,as well as approximately how much battery life remains (e.g., percentageof full charge or time remaining) in the device. In addition to symbolicidentifiers, such as indicator bars 576, any number of numerical,textual, symbolic and/or graphical representations may be displayed inthe delivery status indicator for informing a user as to the status ofany number of conditions of the portable infusion device.

Some portable infusion device embodiments may also alert a user (e.g.,sound a noise, vibrate the device, flash the display screen) when thestatus of any number of device conditions reach a pre-programmed oruser-defined condition level, or condition state. For example, the usermay program the portable infusion device 110 to alert the user when thecartridge contains less than fifty units of insulin. By way of furtherexample, the portable infusion device may also alert a user by any meansdescribed herein to inform the user when a programmed delivery ofinsulin is interrupted for any reason; that the maximum allowabledelivery of insulin for a user has been reached, that a user profileand/or insulin delivery profile setup information is incomplete, thatthe insulin cartridge was not correctly loaded into the housing, thatthe insulin cartridge is empty, that there is an occlusion preventingdelivery, that the system is malfunctioning, and/or any conditionappropriate for alerting a user as to the status of the portableinfusion device 110. Any one of the alerts may be customized by the userto alert at user-defined condition levels, or conditional states, ingenerally any way that the user prefers (e.g., vibrate the device, sounda noise, flashing display, etc.). As broadly illustrated by way ofexample in the information architecture 460 in FIG. 26, a user may setupone or more of the alerts discussed herein by selecting the optionsobject 478 on the home screen page 474, then selecting the “my pump”object 578 on the options page. The user may then be directed to a “mypump” (not shown) page where a user may select an alert settings object,which may then direct a user to setting up one or more alert settings,as discussed above.

FIG. 44 illustrates one example of an alert page 580 which may appear onthe display screen 450 alone or in combination with any of the alertsdescribed above to alert a user as to any number of conditions. An alertpage 580 may include one or more text, graphics, animation and/or videofor informing a user as to the alert being made. Additionally, differentfeatures and/or colors may be applied to particular informationdisplayed on the display screen for emphasizing the information. Forexample, the current BG object 582 (displaying the user's current bloodglucose level), as shown in FIG. 44, may be displayed in red in order tofurther direct the user's attention to the information causing thealert, such as a high blood glucose (BG). Furthermore, a user may beable to directly modify a displayed modifiable object associated withinformation either directly or indirectly related to the alert beingmade. Therefore, the user may be able to efficiently learn and repair(e.g., by selecting the correct object on alert page 580 to correct theerror by any means described herein for entering and/or modifying asetting or value) the condition which caused the portable infusiondevice 110 to display an alert on an alert page 580

FIGS. 45-47 illustrate display pages that show one example of ananimation 584 for instructing a user on how to operate the portableinfusion device 110. In particular, the animation 584 may include textand graphics, of which any may be animated on the display screen 450,for instructing a user on how to remove, install and fill a cartridge ina housing of the portable infusion device 110. An animation 584 may bean efficient and user-friendly means for assisting, instructing, and/orinforming a user on how to operate the portable infusion device 110,which may enhance the usability of the device 110. Furthermore, audiomay accompany any animation 584 for further assisting and/or instructinga user. Such audio may include, singly or in combination, voice, tones,music, vibrational alerts, etc. The portable infusion device 110 maypresent to a user any number of animated graphics and/or videos (with orwithout accompanied audio) for at least assisting, informing, and/orinstructing a user on how to operate the device 110; what is wrong andhow to fix a current malfunction of the device 110; the status of aprogrammed delivery of insulin; or any feature and or functionassociated with the portable infusion device, as described herein. Theportable infusion device 110 may further include a help menu page (notshown) in the GUI page hierarchy whereby a user may select one or morelisted animations and/or videos relating to, for example, operating thedevice. Animated graphics and/or videos may also appear at any time onthe display screen 450 and are not limited to only when a user selectsan animation 584 or video to appear on the display 450.

In addition, a selectable help object 466 may appear on any page withinthe GUI page 456 hierarchy that, when selected by a user, directs a userto a help page. The help page may be a generic help page, which maydescribe general instructions on how to use the device 110.Additionally, a help page may be tailored to the page 456 from which thehelp object 466 appeared on. For example, a user who selects a helpobject 466 on a bolus confirmation page 514 would be directed to a helppage displaying at least information regarding how to set up the device110 to deliver a bolus of insulin. Furthermore, one or more help objects466 may be displayed on a single page being displayed on the touchscreen 452 display 450, with each help object 466 relating to varioushelp information, e.g., definitions of settings, instructions on how toexecute a function, etc.

FIG. 41 illustrates an embodiment of an options page 588, for insulindelivery, which may be accessed once a user, for example, selects theoptions object 478 on the home screen page 474 (refer to FIGS. 26 and27). The options page 588 includes a list of objects 466 that, whenselected, direct a user to various settings, operations, functions andinformation of the portable infusion device 110. For instance, theoptions page 588 may include a stop insulin object 590, which allows auser to stop the active delivery of insulin to the user upon selectionof the stop insulin object 590. Alternatively, the stop insulin object590 may be a resume insulin object (not shown) for allowing a user toresume the delivery of insulin from the device to the user uponselection of the resume insulin object.

The options page 588 may also include a history object 592 that, whenselected by a user, directs a user to be able to view one or morehistory profiles that may include any number of information relating toa delivery of insulin that was made to a user (e.g., time and durationinsulin was delivered, units of insulin delivered, physiologicalconditions recorded, etc.). Generally, any information entered by theuser, processed by the processor 170, or sensed by the device 110 may bestored in memory 172 and recalled by the user in one or more historyprofiles.

Additionally, the options page 588 may list a load object 594 that, whenselected by a user, may direct a user on how to load and unload acartridge into a housing of the portable infusion device 110; fill theinfusion tubing with fluid to be delivered to a user; and fill a cannulawith fluid to be delivered to a user. Generally, selection of the loadobject 594 by a user allows a user to prepare the device 110 for properdelivery of insulin after loading a cartridge into the housing of theportable infusion device 110. As mentioned above, video and or animation584 may be displayed on the touch screen 452 display 450 for assistingin informing and instructing a user on how to do any of theaforementioned tasks, with or without audio accompaniment.

A user may also select the temp rate object 596 on the options page 588to allow a user to set a percentage of the current basal rate to bedelivered for a temporary period of time. For example, a user may wantto program a temp rate of eighty percent for a period of two hoursbecause the user is planning to exercise for an hour. After the definedperiod of time is over, the portable infusion device 110 returns to thebasal rate that was set prior to activation of the temp rate.

The options page 588 also allows a user to initiate the programming ofone or more delivery profiles 458. Depictions of various deliveryprofile setup pages 598 are shown in FIGS. 42A-42L. A reference to “FIG.42” without a letter suffix will be understood to be a reference to thedelivery profile workflow 600 generally. FIG. 42 illustrates one exampleof a delivery profile workflow 600 in an insulin delivery context thatmay direct a user to setting up a new delivery profile 458, whichincludes a number of queries, confirmations, and opportunities for auser to view and modify information regarding a delivery profile 458. Adelivery profile 458 allows a user to customize the delivery of insulin,based on a number of settings, over a twenty-four hour period, which maybe referred to as a personal delivery profile 604. However, a user maychoose to activate any one personal delivery profile 604 at any time,but only one personal delivery profile 604 may generally be activated ata time. Furthermore, a personal delivery profile 604 may be comprised ofone or more time segments 602. Each time segment 602 may define onesetting for the defined period of time, as will be discussed in moredetail below.

By way of example, and broadly shown in FIG. 42, a user may initiate thesetup of a new delivery profile 458, or personal delivery profile 604,by selecting the options object 478 on the home screen page 474,followed by the personal delivery profiles object 606 on the optionspage 588. To initiate the setup of a new personal delivery profile 604,the user may select the new object 608, as illustrated in FIG. 42A.Alternatively, a user may select one of the listed personal deliveryprofiles 604, if one exists, to be the active delivery profile. If theuser selects to program a new personal delivery profile 604, the usermay be prompted with a first query 610 to name the profile. A virtualkeypad 500 containing lettered virtual keys 502 for allowing the user toselect one or more virtual keys 502 may be displayed on the touch screen452 to allow the user to name the personal delivery profile 604. Theuser may then be prompted with a second and third query 612, 613 to seta max basal value (the largest volume allowed for a basal) and a basalrate value (the rate at which the basal is delivered to the user),respectively. A virtual numeric keypad 500 may appear on the touchscreen 452 display 450 for allowing a user to enter values to inresponse to the second and third, or any, query 612, 613. Alternatively,or in addition, a custom setup page, such as the basal rate setup page616 illustrated by way of example in FIG. 42B may be displayed on thedisplay screen 450 for allowing a user to set the basal rate and basaldelivery start time. Each time a user completes defining a basal ratetime segment 602, the user may select the add object 618 to defineadditional basal rate time segments 602.

In some embodiments, the max basal may be programmed in the device 110to be a factor of the programmed standard basal rate. For example, oncea standard basal rate has been programmed in the device 110 for aparticular user, the device would generally automatically determine amax basal based on the programmed basal rate. By way of further example,the max basal may be calculated to be 1.5 to 3 times the standard basalrate, or profile basal rate. This may provide an additional safetyfeature by preventing a user from delivering too large of a bolus fromthe device 110.

FIG. 42C illustrates an example of a basal rate personal profileconfirmation page 620 displayed to a user to view the one or more basalrate time segments 602 defined by the user for the new delivery profile.A user may select any one of the listed basal rate time segments 602 tofurther edit or delete a time segment 602, or the user may select thesave object 622 to save the programmed basal rate time segments 602 andmove on to the next query in the delivery profile workflow. Selection ofa save object 622 on any page 456 generally informs the processor 170 tostore one or more information into memory 172. For example, andillustrated by way of example in FIG. 42C, a pop-up menu 624 may appearon the touch screen 452 display 450 when a user selects any one of thelisted basal rate time segments 602 displayed on the personal profilebasal rate confirmation page 620. A user may select any one of thelisted options displayed in the pop-up menu 624, or the user may select,for example, any part of the touch screen 452 display 450 outside of thepop-up menu 624 to cause the pop-up menu 624 to close. Furthermore, auser may continue to add basal rate time segments 602 by selecting anadd object 618 on a confirmation page, which may direct a user back to asetup page, such as the basal rate setup page 616, as shown in FIG. 42B.For example, a user may define sixteen different basal rate timesegments 602 for any given personal delivery profile 604, which mayallow a single personal delivery profile's 604 basal rate to vary up tosixteen times over a given twenty-four hour period.

As illustrated in FIG. 42, once a user has confirmed and saved at leastone basal rate time segment 602 for the new personal delivery profile604, the user is prompted with generally a fourth query 626 asking theuser to define and confirm a max bolus. Once the user has defined a maxbolus, the user may then be presented with generally a fifth query 628asking whether the user would like to setup one or more correction bolustime segments 602. A correction bolus may be defined as the amount auser's blood sugar will go down in response to the delivery of a unit ofinsulin. If the user chooses to setup a correction bolus, the user ispresented with a series of queries asking the user to setup and confirmone or more BG correction factor time segments 602, as shown in FIGS.42, 42D and 42E, respectively. The steps described above for a user toset up, confirm and add one or more basal rate time segments 602 areessentially identical to the steps for setting up, confirming and addingone or more BG correction factor time segments 602 such that it will notbe repeated here for the sake of simplicity.

As illustrated in FIG. 42, once a user has saved at least one BGcorrection factor time segment 602 for the new personal delivery profile604, the user is prompted with generally a sixth query 628 asking theuser to define and confirm one or more correction target BG timesegments 602. A target BG may be defined as what the user would prefertheir BG level to be. The user is presented with a correction target BGsetup page 632 and target BG confirmation page 634, as shown in FIGS.42F and 42G, respectively. The steps described above for a user to setup, confirm and add one or more basal rate time segments 602 areessentially identical to the steps for setting up, confirming and addingone or more target BG time segments 602 such that it will not berepeated here for the sake of simplicity.

As illustrated in the personal delivery profile workflow 600 in FIG. 42,if the user elects not to setup a correction bolus, the user's “insulinon board” (IOB) will automatically be approximately tracked usingvarious information (e.g., the rate at which the user's body metabolizesinsulin, the amount of insulin delivered to the user over a period oftime. etc.) entered into an algorithm accessible by the processor 170.

The final steps of setting up a new personal delivery profile 604include defining an insulin duration and a bolus delivery value, asillustrated in the personal delivery profile workflow 600 in FIG. 42. Auser may be presented with generally a seventh query 636 to setup aninsulin duration, which approximately defines the time it takes for theuser to metabolize a bolus of insulin. FIG. 42H illustrates oneembodiment of an insulin duration setup page 638 where a user may enteror modify the number of hours and minutes it takes the user tometabolize a bolus of insulin.

The user may then be directed to a food bolus setup page 640, asillustrated in FIG. 42I, which may also be generally the eighth query642 in the personal delivery profile workflow 600. From the food bolussetup page 640, a user may select a bolus delivery value based on thequantity (e.g., number of) of carbohydrates the user predicts toconsume, or the user can choose to directly enter the total units ofinsulin to be delivered in the bolus. If the user chooses to base bolusdelivery values on the predicted amount of carbohydrates to be ingested(in e.g., grams), the user may then be directed to a carb ratio setuppage 644 and subsequent confirmation page 646, as illustrated in FIGS.42J and 42K, respectively, and shown generally as the ninth query 648 inthe personal delivery profile workflow 600. The user is then able todefine at least one carb ratio time segment 602 (defined as the numberof carbs a user must ingest for the device to deliver a single unit ofinsulin during the specified time segment 602) for the new personaldelivery profile 604. The steps described above for a user to set up,confirm and add one or more basal rate time segments 602 are essentiallyidentical to the steps for setting up, confirming and adding one or morecarb ratio time segments 602 such that it will not be repeated here forthe sake of simplicity.

The final steps a user may make in setting up a new personal deliveryprofile 604, for some embodiments, such as those illustrated here in theinsulin delivery context, may be to select to have the quick bolusfeature “on” or “off,” which may also be the tenth query 650 in thepersonal profile delivery workflow 600. If the user chooses to turn thequick bolus feature “on,” the user must define the increment of a quickbolus (either in grams of carbohydrates, or units of insulin). A quickbolus, as will be discussed in more detail below, allows a userefficiently to deliver a bolus quickly defined by the user. By way ofexample, the portable infusion device 110 may include a hard button (notshown) positioned at a convenient location for the user to simply pressat least once to activate the delivery of a quick bolus to the user.Once the user has defined the quick bolus increment, the user hasgenerally completed setting up the new personal delivery profile 604 andis able to save the personal delivery profile 604 for either immediateuse or to be activated at a later time. By way of example, the portableinfusion device 110 may be able to save any number of different personaldelivery profiles 604 for a user to save and select for activating atany time. In one embodiment, the portable infusion device may be able tosave up to 10 or more different delivery profiles. In anotherembodiment, the portable infusion device may be able to save up to 8different delivery profiles. In yet another embodiment, the portableinfusion device may be able to save up to six different deliveryprofiles.

As mentioned above, the portable infusion device 110 may include a quickbolus delivery function which allows a user to quickly deliver a bolusof insulin to a user. Depictions of various quick bolus deliveryconfiguration pages 652 are shown in FIGS. 43A-43D. A reference to “FIG.43” without a letter suffix will be understood to be a reference to thedelivery configuration workflow generally. FIG. 43 illustrates oneexample of a quick bolus delivery workflow 651, which includes actionsperformed by a user for delivering a quick bolus of insulin to a user.For example, the quick bolus may be initiated by a user pressing andholding down a hard button (which may be referred to as the “wake” or“bolus” button) conveniently positioned on the portable insulin device110. An embodiment of the home screen page may or may not be displayedon the touch screen 452 display 450 when the quick bolus delivery isinitiated, and is not necessary for activating the delivery of a quickbolus.

Once the user presses and holds the hard button, a quick bolus deliveryconfiguration page 652 is displayed on the touch screen 452 display, asillustrated in FIG. 43A. The user may then be presented with a firstquery 654 generally asking the user to press the hard button one or moretimes to increase the number of grams of carbs the user predicts toingest. Each time the user presses the hard button in response to thefirst query 654, the grams of carbs and units of insulin increase by thequick bolus increment defined by the user in the currently activatedpersonal delivery profile 604. The currently activated personal deliveryprofile 604 also includes a saved carb ratio which allows theappropriate units of insulin for delivery to be calculated.

For example, a user may have defined a quick bolus increment to be fivegrams, and a carb ratio of 0.5 units of insulin for every five grams ofcarbs. Therefore, each time the user presses the hard button in responseto the first query 654 of the quick bolus workflow 651, the grams ofcarbohydrate increase by five grams and the units of insulin increase by0.5 units. Therefore, if the user presses the hard button three times inresponse to the first query 654 of the quick bolus workflow 651, thequick bolus programmed to be delivered to the user would be 1.5 units ofinsulin, as shown by way of example in FIG. 43B.

Once the user has completed defining the number of units to be deliveredin the quick bolus, the user is prompted with a second query 656, asillustrated in FIG. 43, asking the user to press and hold the hardbutton to initiate the delivery of the quick bolus. The user may thencancel the delivery, or press and hold the hard button to initiate thedelivery of the quick bolus. The portable infusion device 110 providesthe user with a notification (e.g., vibrate the device, an audible alertnoise) to notify the user that the quick bolus delivery has beeninitiated. A countdown timer 542 is also initiated, as shown by way ofexample in FIG. 43C, to allow a user one or more seconds to select thecancel object and cancel the delivery of the quick bolus. A quick bolusconfirmation page 658 may be presented to the user, as illustrated byway of example in FIG. 43D, as the actual delivery of insulin isinitiated to the user.

Alternatively, a user may define a quick bolus increment in terms ofunits of insulin so that each time a user presses the hard button inresponse to the first query of the quick bolus workflow 654, the quickbolus volume is increased by the defined units of insulin. Therefore, auser may define a quick bolus increment to be one unit, so that eachpress of the hard button in response to the first query 654 in the quickbolus workflow 651 increases the quick bolus by one unit. Althoughdescribed by way of example as pressing a hard button, any number ofuser interactions with the portable infusion device 110 may be completedby the user to define and initiate a quick bolus. A quick bolus may bedefined while programming one or more personal delivery profiles 604 sothat when a particular personal delivery profile 604 is activated, thevolume of a quick bolus depends on what the user programmed the volumeof a quick bolus to be for that particular personal delivery profile604. Alternatively, the device 110 may have a universal quick bolusvolume that may be defined by the user, which is not dependent upon thecurrently activated personal delivery profile 604. Instead, when theuser activates the delivery of a universal quick bolus, the volume ofthe quick bolus will always be the same, regardless of which personaldelivery profile 604 is activated. This may be an additional safetyfeature of the portable infusion device 110, because it generallyrelieves the user from having to at least be aware and recall whatpersonal delivery profile 604 is currently active and what the volumefor the quick bolus was programmed for the active personal deliveryprofile 604. For example, with a universal quick bolus, the user may beable to know that each time the user presses the hard button whilesetting up a quick bolus, the volume increases by five units, regardlessof which personal delivery profile 604 is currently active.

An additional feature of the portable infusion device 110 includes abolus delivery delay feature, which allows a user to at least define abolus delivery volume, as well as define a delay in time before thebolus is delivered. For example, once a user has defined the bolusdelivery (either by way of entering predicted carb intake or directlyentering units of insulin), a user may either define a later time tostart the bolus delivery (e.g., bolus delivery starts at 2:00 pm), or atime delay (e.g., bolus delivery starts in one hour). This feature maybe particularly beneficial to children who may be more sensitive tobolus deliveries and may need an adult to assist in the setup of a bolusdelivery, which may be more appropriately delivered at a later time(e.g., while the child is at school).

Another feature of some embodiments allows a user to set up a personaldelivery profile 604, as was described and illustrated in FIGS. 42-42L,but instead of setting one or more time segments 602 for each setting ofa personal delivery profile 604 (e.g., basal rate, BG correction factor,carb ration, target BG), the user may define each setting within asingle time segment 602.

FIG. 48 illustrates one example of a personal delivery profile timesegment setup page 660 where the multiple personal delivery profile 604settings are displayed (for editing or confirmation) within a singletime segment 602, or start time. For some configurations, the user maydefine multiple settings within a single time segment 602, thuseliminating the need to define time segments 602 for each setting.Additionally, the user may scroll down the touch screen 452 display 450(e.g., by dragging a finger in a downward direction or selecting eitherthe up object 662 or down object 664) to cause additional settings andor information regarding the personal delivery profile 604 to appear(e.g., max bolus, quick bolus). From the personal delivery profile timesegment setup page 660, a user may define and/or modify any one of thepersonal delivery profile 604 settings for the time segment 602. Thesegment of time itself may also be defined and/or modified.

FIG. 49 illustrates an embodiment of a personal delivery profileconfirmation page 666 displaying one or more personal delivery profile604 settings for each time segment 602. It is one advantage of theportable infusion device 110 to offer a user with a condensed view ofmultiple personal delivery profile 604 time segments 602 and theirassociated settings, as shown in the personal delivery profileconfirmation page 666 illustrated by way of example in FIG. 49. Forexample, a user may be able to view and compare multiple personaldelivery profile 604 settings over multiple time segments 602 on asingle touch screen 452 display 450. Furthermore, a user may simplyscroll down the touch screen 452 display 450 (e.g., by dragging a fingerin a downward direction or selecting either the up object 662 or downobject 664) to cause additional time segments 602 to be displayed on thedisplay screen 450. The user may edit, delete and add additional timesegments 602 directly from the personal delivery profile confirmationpage 666.

FIG. 50A illustrates an example of a delivery calculation page 668displaying one or more variable setting used to calculate the totalunits of insulin programmed to be delivered to a user. A user may accessa delivery calculation page 668, for example, by selecting a “viewcalculations” object 670 appearing on a page 456 within the GUI page 456hierarchy, as shown by way of example in FIG. 53A. A deliverycalculation page 668 may list any number of modifiable values and/orsettings used for calculating the total units of insulin programmed tobe delivered to a user. For example, variables used to calculate thetotal units of insulin may include the number of units of insulinnecessary for the number of carbs to be ingested by the user; the numberof units of insulin necessary to reach a defined target BG level; andthe number of units of insulin currently in the user's body.

Furthermore, and shown by way of example in FIG. 50B, a user may scrolldown a delivery calculation page 670 to view a personal settings page672. The personal settings page 672 may list one or more settings (e.g.,carb ratio, BG correction factor, target BG) that may also have beenused to determine the total units of insulin programmed to be deliveredto a user. At least one of the settings displayed on the deliverycalculation page 670 and personal settings page 672 may be directlymodified by a user using any of the methods described herein formodifying a value displayed on the touch screen 452 display 450.Therefore, a user may at least view and modify any one of the settingslisted on either the delivery calculation page 670 or personal settingspage in order to modify the total units of insulin programmed to bedelivered to a user.

FIG. 51 illustrates an additional embodiment of a home screen page 674that may be displayed on the touch screen 452 display 450 of theportable infusion device 110. In this particular embodiment, the homescreen page has been configured to include one or more status indicatorobjects 480, a bolus object 482, an options object 478, and an IOBobject 486, of which any object may be a soft key so that the user mayselect any one of the selectable objects. For instance, a user mayselect the options object 478, which may direct the user to an optionspage 588, as described above and illustrated by way of example in FIG.41. Additionally, any one of the status indicator objects 480 may beselected to either view or modify, as described above. Furthermore, theIOB object 486 may display the units of insulin remaining from thedelivery of one or more bolus deliveries of insulin to the user. The IOBobject 486 may also display the time remaining for the body of the userto metabolize the remaining bolus units of insulin. In addition, a usermay select the bolus object, which may direct a user to a bolus setuppage for setting up a bolus delivery of insulin.

FIG. 53A illustrates another embodiment of a bolus setup page 676 thatmay be displayed on the touch screen 452 display 450 of the portableinfusion device 110. The bolus setup page 676 is shown as including afood bolus object 678, a BG object 484, a view calculation object 670,an extended bolus object 524, and navigation object 510, e.g., back,skip, next, of which any object may be a soft key so that the user mayselect any one of the selectable objects. This embodiment of the bolussetup page 676 may be configured to enable the user to simply select anyone of the settings to enter or modify a value. For example, the usermay select the food bolus object 526 to enter the number of grams ofcarbs the user predicts to consume. As discussed above, a virtual keypad500 may be displayed on the touch screen 452 display 450 for enabling auser to enter the number of grams of carbs, or any means for entering ormodifying a value described herein. Once the user enters the number ofcarbs, the user is then directed back to the bolus setup page 676.

One embodiment of the virtual keypad 500 may include one or moremathematical symbol virtual keys 502, e.g., plus sign, minus sign,multiplication sign, division sign, etc., to enable the virtual keypad500 and processor 170 to function as a virtual calculator. For example,a virtual keypad 500 with one or more mathematical symbols displayed onthe display screen 450 may enable a user to enter more than one entryand instruct the processor 170 to, for example, add, subtract, multiply,and/or divide the user entries. For instance, a user may be presentedwith a virtual calculator for enabling a user to enter and add more thanone amount of carbs making up at least a part of a meal the user intendsto consume. This feature may improve usability of the device 110 andreduce user error by simplifying the means by which a user determinesthe total number of carbs that make up a meal the user intends toconsume, in addition to generally relieving the user from having toperform the calculations that may be necessary to determine the totalnumber of carbs. As mentioned above, a virtual keyboard 500 includingone or more mathematical virtual key 502 symbols may be presented to auser for various reasons and opportunities for a user to instruct theprocessor 170 to perform one or more calculations.

In addition, from the bolus delivery setup page 676 a user may choose toprogram an extended bolus, as illustrated in FIGS. 53A and 53B showing avirtual slide button 680 exposing either “on” or “off” in response to auser selecting to either program or not program an extended bolus,respectively. A user may select to program an extended bolus, e.g., bysliding a finger over the virtual slide 680 button to cause the virtualslide button 680 to move and display the “on” and then selecting thenext object, as illustrated in FIG. 53B, which may direct a user to anextended bolus setup page 682. Once the user completes setting up anextended bolus on the extended bolus setup page 682, the user isdirected back to the bolus setup page.

FIG. 53C illustrates another example of an extended bolus setup page 682that may be displayed on the touch screen 452 display 450 of theportable infusion device 110. The extended bolus setup page 682 is shownas including a deliver now object 550 (how much insulin is programmed tobe delivered generally immediately after the user initiates the extendedbolus delivery), a deliver later object 552 (how much insulin isprogrammed to be delivered over an extended period of time), a foodbolus object 526 (how much insulin is programmed to be delivered to auser based generally on the amount of food, or carbs, the user predictsto consume), a duration object 548 (over what period of time theextended bolus will be delivered), and navigation objects 510, e.g., aback, next, done. Any of the objects displayed on the extended bolussetup page 682 may be a soft key for enabling a user to select any oneof the objects. Furthermore, and similar to the bolus delivery setuppage 676, a user may select any one of the selectable objects displayedon the touch screen 452 display 450 to enter or modify any of thesettings using any means described herein for modifying selectableobjects, e.g., entering a value by selecting virtual keys 502 on avirtual keypad 500 displayed on the touch screen 452 display 450.

As described above, once the user completes setting up an extended boluson the extended bolus setup page 682, the user may select the doneobject 506 on the extended bolus setup page 682 to be directed back tothe bolus delivery setup page 676. Once the user is directed back to thebolus delivery setup page 676, the user may either modify any of thesettings displayed on the touch screen 452, select the back object 510to be directed to a previous page, or select the done object 506 toinitiate delivery of the extended bolus.

Alternatively, a user may not have selected to setup an extended bolus,e.g. by positing the virtual slide button 680 to allow the “off” to bedisplayed as shown in FIG. 53A, and may have, instead, selected the doneobject 506 after entering or modifying one or more settings on the bolusdelivery setup page 676 to initiate delivery of a standard bolus.

Therefore, the embodiment of the bolus delivery setup page 676illustrated in FIGS. 53A and 53B enable a user to setup a bolus deliverywithout navigating through a generally linear workflow 464 or a seriesof queries. Instead, the user may select any one of the selectablesettings displayed on the single bolus delivery setup page 676 on thetouch screen 452 display 450 to either enter or modify one or more ofthe bolus delivery settings.

Once the user has completed setting up either a standard or extendedbolus and has confirmed delivery of the bolus, the user may be directedback to a home screen page 674. FIG. 52 illustrates the home screen page674 which includes one or more delivery status indicators and a stopinsulin object 590. The one or more delivery status indicators 684 mayvisually change, e.g., color, brightness, etc., either separately or inunison so that it is generally obvious to a user that the delivery ofthe bolus has at least been initiated. In addition, when the deliverystatus indicators 684 stop visually changing, it may be obvious to auser that the delivery of the bolus is complete.

Additionally, and shown by way of example in FIG. 52, another embodimentof a stop insulin object 590 may be displayed on the home screen 674page. A stop insulin object 590 may only appear on the home screen page674 after a delivery has been initiated, and remain displayed until thedelivery has been completed. This feature enables a user to easilyaccess and stop a programmed delivery of insulin while there isgenerally an opportunity to do so. Having the stop insulin object 590 onthe home screen page 674 may improve the user's safety by enabling theuser to select the stop insulin object 590 to stop delivery more quicklythan having to navigate through one or more additional pages, which maydecrease the amount of unwanted insulin delivered to the user.

As discussed above, the GUI 454 may display various information ingraphical form, and the graphic representation 570 may be configured formanipulation by a user touching or otherwise “clicking” therepresentation and dragging the representation in a predefined manner soas to change the form, e.g., height, width, shape, etc. of therepresentation. For example, where the graphical representation 570 is abar, the height or width of the bar may be adjusted by clicking on theappropriate dimension and manipulating it to adjust that chosendimension. Where the graphical representation 570 is a curve or wave,the curve or wave may be clicked and the shape thereof may then bemanipulated, for instance, by dragging a finger across the screen in apredetermined manner.

FIG. 54 illustrates an example of multiple graphs 570 simultaneouslydisplayed on the touch screen 452 display 450, which may collectivelyinform a user as to the range and optimal levels of a user's BGprogrammed into the portable infusion device 110. The graphs 570simultaneously displayed may include a high blood glucose (BG) graph, alow BG graph and an optimal BG graph. However, any number of graphs 570representing various information may be simultaneously displayed on thetouch screen 452 display 450 of the portable infusion device 110.Furthermore, the graphs 570 shown in FIGS. 54 and 55 are illustrated forexample purposes and do not limit the shape, e.g., slope, geometry,etc., or configuration of the graphical representations shown ordiscussed herein.

In addition, the information represented by at least one of the graphs570 may be used to calculate and determine additional settings. Forinstance, the high BG graph 686 may display the range of a user'sacceptable high BG levels over a period of time, the low BG graph 688may display the range of acceptable low BG levels over a period of time,and the optimal BG graph 690 may display the range of optimal BG levelsover a period of time. For example, a user's high BG level range mayinfluence the occurrence and amount of correction boluses delivered to auser. Therefore, a user may modify, for example, the programmed high BGlevel range in order to modify the occurrence and amount of correctionboluses programmed to be delivered to the user.

FIG. 55 illustrates another example of multiple graphs 570simultaneously displayed on the touch screen 452 display 450, which maycollectively inform a user as to the composition of insulin programmedto be delivered to a user. For instance, and shown by way of example inFIG. 55, a correction bolus graph 692 may display what percent of theinsulin programmed to be delivered to a user over a period of time is acorrection bolus. In addition, a meal bolus graph 694 may display whatpercent of the insulin programmed to be delivered to a user over aperiod of time is a meal bolus (based on a user's carb ratio), and abasal graph 696 may display the basal delivery rate of insulinprogrammed to be delivered to a user over a period of time. Thesimultaneously displayed graphs 570 may provide a user with a simplifiedway to at least view, compare, and/or modify various programmedinformation over a period of time.

Furthermore, any one of the graphs 570 may be configured formanipulation by a user, such that a user may modify the range of any oneof the graphs 570. For example, a user may want to modify the high BGrange, e.g., by selecting and dragging a part of the high BG graph 686,in order to decrease the percentage of correction bolus comprising thetotal amount of insulin delivered to a user over a period of time.Therefore, modification of one graph 570 may generally causemodification to one or more additional graphs 570, which may result inimproved usability of the portable infusion device 110 for a user to atleast manage their insulin therapy.

With regard to the above detailed description, like reference numeralsused therein may refer to like elements that may have the same orsimilar dimensions, materials and configurations. While particular formsof embodiments have been illustrated and described, it will be apparentthat various modifications can be made without departing from the spiritand scope of the embodiments herein. Accordingly, it is not intendedthat the invention be limited by the forgoing detailed description.

The entirety of each patent, patent application, publication anddocument referenced herein is hereby incorporated by reference. Citationof the above patents, patent applications, publications and documents isnot an admission that any of the foregoing is pertinent prior art, nordoes it constitute any admission as to the contents or date of thesedocuments.

Modifications may be made to the foregoing embodiments without departingfrom the basic aspects of the technology. Although the technology mayhave been described in substantial detail with reference to one or morespecific embodiments, changes may be made to the embodimentsspecifically disclosed in this application, yet these modifications andimprovements are within the scope and spirit of the technology. Thetechnology illustratively described herein suitably may be practiced inthe absence of any element(s) not specifically disclosed herein. Thus,for example, in each instance herein any of the terms “comprising,”“consisting essentially of,” and “consisting of” may be replaced witheither of the other two terms. The terms and expressions which have beenemployed are used as terms of description and not of limitation, and useof such terms and expressions do not exclude any equivalents of thefeatures shown and described or portions thereof, and variousmodifications are possible within the scope of the technology claimed.The term “a” or “an” may refer to one of or a plurality of the elementsit modifies (e.g., “a reagent” can mean one or more reagents) unless itis contextually clear either one of the elements or more than one of theelements is described. Although the present technology has beenspecifically disclosed by representative embodiments and optionalfeatures, modification and variation of the concepts herein disclosedmay be made, and such modifications and variations may be consideredwithin the scope of this technology.

Certain embodiments of the technology are set forth in the claim(s) thatfollow(s).

1. An infusion pump system, comprising: a pump device including ahousing, a drive mechanism with a motor, a controller operativelycoupled to the drive mechanism and a slot configured to accept adisposable fluid cartridge; a disposable fluid cartridge which may beoperatively coupled to the housing, the cartridge including a deliverymechanism, a collapsible reservoir having an interior volume surroundedby a flexible fluid tight membrane, the interior volume being in fluidcommunication with a reservoir inlet port, the cartridge also includinga substantially rigid shell disposed over the reservoir and forming asecond interior volume between an outside surface of the reservoir andan inside surface of the rigid shell with a vent inlet port incommunication with the second interior volume; a pressure sensordisposed between an interior surface of the rigid case and an exteriorsurface of the collapsible reservoir shell; a bore within a pump body ofthe delivery mechanism; and a spool slidingly disposed in the borehaving a collapsible first volume which is configured to communicatewith the reservoir inlet port and dispense port of the boreindependently of each other.
 2. The system of claim 1 wherein at leastone seal is always disposed between the reservoir inlet port anddispense port so as to prevent a free flow condition to the dispenseport from the reservoir.
 3. The system of claim 1 wherein thecollapsible first volume is formed between two seals disposed on thespool body an outside surface of the spool body, an inside surface ofthe bore and an outside surface of the spool body disposed between thetwo seals with the seals axially displaceable relative to each other toform a collapsible volume between the two seals.
 4. The system of claim1 wherein the pressure sensor is configured to measure small changes inpressure at low pressures.
 5. The system of claim 4 wherein the pressuresensor is configured to measure pressures up to about 30 psi.
 6. Thesystem of claim 5 wherein the pressure sensor is configured to measurepressures up to about 5 psi.
 7. The system of claim 1 wherein the sealsof the spool comprise o-rings disposed in angled grooves having overflowgrooves below and in communication with the angled grooves.
 8. Thesystem of claim 1 wherein the collapsible first volume comprises asection of the spool disposed between the seals of the collapsible firstvolume that is axially collapsible to allow the seals of the collapsiblefirst volume to axially converge and reduce the volume of thecollapsible first volume.
 9. An infusion pump for dispensing fluid to apatient, comprising: a disposable fluid cartridge including: a deliverymechanism including: a delivery mechanism body, a bore disposed in thedelivery mechanism body including a distal end, a proximal end disposedtowards a drive mechanism of the infusion pump, an interior volume, areservoir inlet port, a fluid dispense port, a spool slidingly disposedwithin the bore including a collapsible first volume which ispositionable to overlap the reservoir inlet port independent of anoverlap of the fluid dispense port and which is formed between a firstseal around the spool, a second seal around the spool, an outer surfaceof the spool body between the first and second seal and an interiorsurface of the bore between the first and second seal, the first andsecond seals being axially moveable relative to each other; acollapsible fluid reservoir bounded by a flexible membrane and includingan interior volume in fluid communication with the reservoir inlet port;a substantially rigid shell disposed about the collapsible fluidreservoir with an interior volume that contains the collapsible fluidreservoir and a volume disposed between an outer surface of the flexiblemembrane and an interior surface of the rigid shell; a drive mechanismoperatively coupled to the spool of the delivery mechanism; a userinterface configured to accommodate user data input regarding fluiddelivery; a controller having a processor and memory device operativelycoupled to the drive mechanism; and a power cell operatively coupled tothe controller, the GUI and the drive mechanism.
 10. The pump of claim 9wherein the first and second seals comprise o-rings disposed in angledgrooves having overflow grooves below.
 11. The system of claim 9 whereinthe collapsible first volume comprises a volume bounded by at least oneseal that is axially displaceable relative to a section of the spoolbody and which forms a substantially fluid tight seal between an outsidesurface of the seal and an inside surface of the bore and a fluid tightseal between an outside surface of a slide portion of the spool and anaperture of the seal.
 12. The system of claim 9 wherein at least oneseal is always disposed between the reservoir inlet port and dispenseport so as to prevent a free flow condition to the dispense port fromthe reservoir.
 13. A method dispensing from an infusion pump system,comprising: providing an infusion pump system including: a disposablefluid reservoir cartridge including: a delivery mechanism including: adelivery mechanism body, a bore disposed in the delivery mechanism bodyincluding a distal end, a proximal end disposed towards a drivemechanism of the infusion pump, an interior volume, a reservoir inletport, a fluid dispense port, a vent inlet port and a vent outlet port; aspool slidingly disposed within the bore including a collapsible firstvolume which is positionable to overlap the reservoir inlet portindependent of an overlap of the fluid dispense port and which is formedbetween a first seal around the spool, a second seal around the spool,an outer surface of the spool body between the first and second seal andan interior surface of the bore between the first and second seal, thefirst and second seals being axially moveable relative to each other; acollapsible fluid reservoir bounded by a flexible membrane and includingan interior volume in fluid communication with the reservoir inlet port,a substantially rigid shell disposed about the collapsible fluidreservoir with an interior volume that contains the collapsible fluidreservoir and a volume disposed between an outer surface of the flexiblemembrane and an interior surface of the rigid shell; and a drivemechanism operatively coupled to the spool of the delivery mechanism;initiating a dispense cycle by driving the spool with the drivemechanism to a position with the collapsible first volume incommunication with the reservoir inlet port; driving the spool so as toseparate the first and second seals of the collapsible first volume anddraw fluid into the first volume through the reservoir inlet port fromthe reservoir thereby decreasing the pressure in the volume between thereservoir and interior surface of the rigid shell; driving the spoolwith the drive mechanism to a position with the collapsible first volumein communication with the fluid dispense port; and driving the spool soas to at least partially collapse the collapsible first volume anddispense fluid from the collapsible first volume through the fluiddispense port.
 14. The method of claim 13 wherein at least one seal isalways disposed between the reservoir inlet port and dispense port so asto prevent a free flow condition to the dispense port from thereservoir.
 15. A delivery mechanism for an infusion pump comprising: abore disposed in a delivery mechanism body; a spool disposed in the borewhich is axially displaceable within the bore; and a collapsible volumebounded by an outside surface of the spool, an inside surface of thebore, a first seal between the spool and the bore that is axially fixedrelative to the spool but displaceable relative to an inside surface ofthe bore and a second seal between the spool and inside surface of thebore which is configured to slide over a slide portion of the spooldisposed in an aperture of the second seal, which forms a substantiallyfluid tight but displaceable seal between an outside surface of thesecond seal and the inside surface of the bore and which forms a fluidtight but displaceable seal between an outside surface of the slideportion and the second seal.
 16. The mechanism of claim 15 wherein thefriction between inside surface of bore and second seal is greater thanfriction between outside surface of slide portion of spool and apertureof second seal.
 17. The mechanism of claim 15 wherein the second sealcomprises an o-ring.
 18. The mechanism of claim 15 wherein the spoolcomprises an elongate cylindrical member having a transverse dimensionof about 0.5 mm to about 10 mm.
 19. The mechanism of claim 15 wherein atleast one seal is always disposed between the reservoir inlet port anddispense port so as to prevent a free flow condition to the dispenseport from the reservoir.
 20. An infusion pump for dispensing fluid to apatient, comprising: a disposable fluid cartridge including: a deliverymechanism including: a delivery mechanism body, a bore disposed in thedelivery mechanism body including a distal end, a proximal end disposedtowards a drive mechanism of the infusion pump, an interior volume, areservoir inlet port, a fluid dispense port, a vent inlet port and avent outlet port; a spool slidingly disposed within the bore including:a collapsible first volume bounded by an outside surface of the spool,an inside surface of the bore, a first seal between the spool and thebore that is axially fixed relative to the spool but displaceablerelative to an inside surface of the bore and a second seal between thespool and inside surface of the bore which is configured to slide over aslide portion of the spool disposed in an aperture of the second seal,which forms a substantially fluid tight but displaceable seal between anoutside surface of the second seal and the inside surface of the boreand which forms a fluid tight but displaceable seal between an outsidesurface of the slide portion and the second seal, and a vent secondvolume which is positionable to overlap the vent inlet port and ventoutlet port simultaneously and which is formed by a third seal aroundthe spool, a fourth seal around the spool, an outside surface of thespool between the third and fourth seal and an inside surface of thebore between the third and fourth seal; a collapsible fluid reservoirbounded by a flexible membrane and including an interior volume in fluidcommunication with the reservoir inlet port, a substantially rigid shelldisposed about the collapsible fluid reservoir with an interior volumethat contains the collapsible fluid reservoir and a vented volumedisposed between an outer surface of the flexible membrane and aninterior surface of the rigid shell, the vent inlet port being in fluidcommunication with the vented volume.
 21. The infusion pump of claim 20further comprising a drive mechanism operatively coupled to the spool ofthe delivery mechanism.
 22. The infusion pump of claim 21 furthercomprising a user interface configured to accommodate user data inputregarding fluid delivery.
 23. The infusion pump of claim 22 furthercomprising a controller having a processor and memory device operativelycoupled to the drive mechanism.
 24. The infusion pump of claim 23further comprising a power cell operatively coupled to the controller,the GUI and the drive mechanism.
 25. The infusion pump of claim 20wherein at least one seal is always disposed between the reservoir inletport and dispense port so as to prevent a free flow condition to thedispense port from the reservoir.
 26. An infusion pump systemcomprising, a housing; a disposable cartridge including a collapsiblereservoir surrounded by a flexible material and a substantially rigidcontainer sealed around the flexible material of the collapsiblereservoir, the cartridge releasably secured to the housing; a disposabledelivery mechanism disposed within the disposable cartridge and havingan reservoir inlet port in fluid communication with an interior volumeof the reservoir; a drive mechanism including a motor disposed in thehousing and detachably coupled to a spool member of the deliverymechanism, the drive mechanism being operatively coupled to the spoolmember; at least one pressure sensor disposed in a volume disposedbetween the outside surface of the flexible material of the reservoirand an inside surface of the substantially rigid container/case; agraphic user interface operatively coupled to a controller; a powerstorage cell; a vent inlet port disposed on the delivery mechanism influid communication with the volume disposed between the outside surfaceof the flexible material of the reservoir and an inside surface of thesubstantially rigid container/case; and a controller including at leastone processor and a memory device, the controller operatively coupled tothe drive mechanism, GUI, and at least one pressure sensor andconfigured to generate a signal to the drive mechanism to displace thespool of the delivery mechanism.
 27. The system of claim 26 wherein thecontroller includes a first low power processor and a second processor.28. The system of claim 26 wherein the energy storage cell comprises abattery.
 29. The system of claim 26 wherein the GUI comprises a touchscreen interface.
 30. The system of claim 26 wherein the system furthercomprises a second pump device with a second controller having aprocessor and memory device coupled thereto, the second pump beingconfigured to operatively couple to the disposable cartridge andincluding a compact configuration with only basic pumping features withno GUI.
 31. The system of claim 30 wherein the first pump device isconfigured to communicate with the second pump device and the GUI of thefirst pump may be used to communicate with the second controller. 32.The system of claim 26 wherein at least one seal is always disposedbetween the reservoir inlet port and dispense port so as to prevent afree flow condition to the dispense port from the reservoir.
 33. Aninfusion pump system comprising, a housing; a disposable cartridgeincluding a collapsible reservoir surrounded by a flexible material anda substantially rigid shell sealed around the flexible material of thecollapsible reservoir, the cartridge releasably secured to the housing;a disposable delivery mechanism disposed within the disposable cartridgeand having a reservoir inlet port in fluid communication with aninterior volume of the reservoir; a drive mechanism including a motordisposed in the housing and detachably coupled to a spool member of thedelivery mechanism, the drive mechanism being operatively and detachablycoupled to the spool member of the delivery mechanism; at least onepressure sensor disposed in a volume disposed between the outsidesurface of the flexible material of the reservoir and an inside surfaceof the substantially rigid container/case; a graphic user interfaceoperatively coupled to a controller; a power storage cell; and acontroller including at least one processor and a memory device, thecontroller operatively coupled to the drive mechanism, GUI, and at leastone pressure sensor and configured to generate a signal to the drivemechanism to displace the spool of the delivery mechanism.
 34. Thesystem of claim 33 wherein at least one seal is always disposed betweenthe reservoir inlet port and dispense port so as to prevent a free flowcondition to the dispense port from the reservoir.